Trial Outcomes & Findings for BI 894999 First in Human Dose Finding Study in Advanced Malignancies (NCT NCT02516553)
NCT ID: NCT02516553
Last Updated: 2024-04-15
Results Overview
Number of patients with Dose Limiting Toxicities (DLTs) observed in the first treatment cycle of Phase Ia is reported. The following drug related adverse events (AEs) qualified as DLT: * any Common Terminology Criteria for Adverse Events (CTCAE) grade ≥3 non haematological toxicity considered related to trial medication with the following exceptions: * inadequately treated nausea, vomiting or diarrhoea. For fatigue, if present at baseline, there had to be an increase of ≥2 grades * electrolytes abnormalities that were corrected within 72 hours with treatment * any haematologic AE related to the trial medication defined as follows: * CTCAE grade ≥4 neutropenia lasting ≥ 7 days and/or complicated by infection, or * CTCAE grade ≥4 thrombocytopenia, or * CTCAE grade≥ 3 thrombocytopenia coupled with grade ≥ 2 of bleeding, or * febrile neutropenia CTCAE grade 3 or higher. * any other drug-related AE preventing the patient from taking his treatment according to the given schedule.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
174 participants
Primary outcome timeframe
First treatment cycle (the first 21 days for Schedules A and B, the first 28 days for Schedule C).
Results posted on
2024-04-15
Participant Flow
This was an open label, Phase Ia/Ib dose finding study with BI 894999 orally administered once a day in patients with advanced malignancies with repeated administration in patients with clinical benefit.
For Phase Ib - Schedule B SCLC, Phase Ib - Schedule B mCRPC, DMC decided on 28Nov2018 to lower the dose of SCLC and mCRPC due to safety concern, thus patients treated prior the decision received 2.5mg BI 894999 and patients treated after the decision received 2mg . For Phase Ib - Schedule C NC, the dose was lowered since DMC reclaimed the MTD as 6/3mg on 08Jul2020 after 1 patient already treated with 7/3.5mg, so the first patient in NC and all the following patients were treated with 6/3mg.
Participant milestones
| Measure |
Phase Ia - Schedule A: 0.2 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 0.2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 0.5 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 0.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 1 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 1 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 1.5 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 2 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 5 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule B: 1.5 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2.5 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2.5 mg of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule C: 5/2.5 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 5 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: 6/3 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: 7/3.5 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 7 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 3.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule B: 1.5 mg BI 894999 (DLBCL Patients)
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2 mg BI 894999 (DLBCL Patients)
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2.5 mg BI 894999 (DLBCL Patients)
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 2.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule C: 4/2 mg BI 894999 (DLBCL Patients)
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 4 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: BI 894999 5/2.5 mg (DLBCL Patients)
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 5 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2.5 mg of BI 894999, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ib - Schedule B: 2 or 2.5 mg BI 894999 (SCLC Patients)
This arm included adult patients diagnosed with small cell lung cancer (SCLC). SCLC patients were initialy administered 2.5 mg of BI 894999. BI 894999 administration was performed in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water according to Schedule B (continuous intake for 14 days followed by one week off treatment in cycles of 21 days).
The Data Monitoring Committee decided on 28 November 2018 to lower the 2.5 mg BI 894999 dose due to safety concerns to 2mg, therefore patients treated before the decision were administered 2.5mg, and patients treated after the decision were administered 2mg.
|
Phase Ib - Schedule B: 2.5 mg BI 894999 (CRC Patients)
Adult patients diagnosed with colorectal cancer (CRC) were administered orally 2.5 milligram (mg) of BI 894999. BI 894999 administration was performed in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water according to Schedule B (continuous intake for 14 days followed by one week off treatment in cycles of 21 days).
|
Phase Ib - Schedule B: 2 or 2.5 mg BI 894999 (mCRPC Patients)
This arm included adult patients diagnosed with metastatic castrate resistant prostate cancer (mCRPC).
MCRPC patients were initialy administered 2.5 mg of BI 894999. BI 894999 administration was performed in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water according to Schedule B (continuous intake for 14 days followed by one week off treatment in cycles of 21 days).
The Data Monitoring Committee decided on 28 November 2018 to lower the 2.5 mg BI 894999 dose due to safety concerns to 2mg, therefore patients treated before the decision were administered 2.5mg, and patients treated after the decision were administered 2mg.
|
Phase Ib - Schedule B: 2.5 mg BI 894999 (NC Patients)
Adult patients diagnosed with NUT carcinoma (NC) were administered orally 2.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days. The 2.5 mg dose could be reduced to 2 mg in case of adverse events.
|
Phase Ib - Schedule C: 6/3 or 7/3.5 mg BI 894999 (NC Patients)
This arm included adult patients diagnosed with NUT carcinoma (NC). The DMC reclaimed the maximum tolerated dose (MTD) as 6/3mg on 08 July 2020 after 1 patient was already treated with 7/3.5mg, so the first patient in NC and all the following patients were treated with 6/3mg.
Patients in were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C).
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Overall Study
STARTED
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2
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2
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3
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6
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6
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2
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6
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6
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13
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4
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15
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12
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8
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4
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2
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2
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2
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12
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14
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11
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20
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22
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Overall Study
COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Overall Study
NOT COMPLETED
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2
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2
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6
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2
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6
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6
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13
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4
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15
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8
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4
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2
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2
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2
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12
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14
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11
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20
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22
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Reasons for withdrawal
| Measure |
Phase Ia - Schedule A: 0.2 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 0.2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 0.5 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 0.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 1 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 1 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 1.5 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 2 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 5 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule B: 1.5 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2.5 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2.5 mg of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule C: 5/2.5 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 5 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: 6/3 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: 7/3.5 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 7 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 3.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule B: 1.5 mg BI 894999 (DLBCL Patients)
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2 mg BI 894999 (DLBCL Patients)
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2.5 mg BI 894999 (DLBCL Patients)
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 2.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule C: 4/2 mg BI 894999 (DLBCL Patients)
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 4 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: BI 894999 5/2.5 mg (DLBCL Patients)
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 5 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2.5 mg of BI 894999, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ib - Schedule B: 2 or 2.5 mg BI 894999 (SCLC Patients)
This arm included adult patients diagnosed with small cell lung cancer (SCLC). SCLC patients were initialy administered 2.5 mg of BI 894999. BI 894999 administration was performed in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water according to Schedule B (continuous intake for 14 days followed by one week off treatment in cycles of 21 days).
The Data Monitoring Committee decided on 28 November 2018 to lower the 2.5 mg BI 894999 dose due to safety concerns to 2mg, therefore patients treated before the decision were administered 2.5mg, and patients treated after the decision were administered 2mg.
|
Phase Ib - Schedule B: 2.5 mg BI 894999 (CRC Patients)
Adult patients diagnosed with colorectal cancer (CRC) were administered orally 2.5 milligram (mg) of BI 894999. BI 894999 administration was performed in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water according to Schedule B (continuous intake for 14 days followed by one week off treatment in cycles of 21 days).
|
Phase Ib - Schedule B: 2 or 2.5 mg BI 894999 (mCRPC Patients)
This arm included adult patients diagnosed with metastatic castrate resistant prostate cancer (mCRPC).
MCRPC patients were initialy administered 2.5 mg of BI 894999. BI 894999 administration was performed in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water according to Schedule B (continuous intake for 14 days followed by one week off treatment in cycles of 21 days).
The Data Monitoring Committee decided on 28 November 2018 to lower the 2.5 mg BI 894999 dose due to safety concerns to 2mg, therefore patients treated before the decision were administered 2.5mg, and patients treated after the decision were administered 2mg.
|
Phase Ib - Schedule B: 2.5 mg BI 894999 (NC Patients)
Adult patients diagnosed with NUT carcinoma (NC) were administered orally 2.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days. The 2.5 mg dose could be reduced to 2 mg in case of adverse events.
|
Phase Ib - Schedule C: 6/3 or 7/3.5 mg BI 894999 (NC Patients)
This arm included adult patients diagnosed with NUT carcinoma (NC). The DMC reclaimed the maximum tolerated dose (MTD) as 6/3mg on 08 July 2020 after 1 patient was already treated with 7/3.5mg, so the first patient in NC and all the following patients were treated with 6/3mg.
Patients in were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C).
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Progressive disease
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2
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2
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3
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5
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3
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0
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5
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5
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11
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3
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10
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8
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8
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2
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2
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2
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1
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9
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12
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7
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16
|
18
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Overall Study
Dose limiting toxicity
|
0
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0
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0
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0
|
3
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1
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1
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0
|
1
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0
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0
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1
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0
|
1
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0
|
0
|
1
|
1
|
0
|
2
|
0
|
0
|
|
Overall Study
Other Adverse Events
|
0
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0
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0
|
1
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0
|
1
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0
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0
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0
|
1
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3
|
2
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0
|
1
|
0
|
0
|
0
|
2
|
1
|
2
|
2
|
1
|
|
Overall Study
Refused to continue trial medication
|
0
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0
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0
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0
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0
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0
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0
|
0
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0
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0
|
1
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0
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0
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0
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0
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0
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0
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0
|
1
|
0
|
0
|
1
|
|
Overall Study
other reasons than listed
|
0
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0
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0
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0
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0
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0
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0
|
1
|
1
|
0
|
1
|
1
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0
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0
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0
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0
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0
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0
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0
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0
|
2
|
2
|
Baseline Characteristics
BI 894999 First in Human Dose Finding Study in Advanced Malignancies
Baseline characteristics by cohort
| Measure |
Phase Ia - Schedule A: 0.5 mg BI 894999
n=2 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 0.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 0.2 mg BI 894999
n=2 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 0.2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 1 mg BI 894999
n=3 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 1 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 1.5 mg BI 894999
n=6 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 2 mg BI 894999
n=6 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 5 mg BI 894999
n=2 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule B: 1.5 mg BI 894999
n=6 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2 mg BI 894999
n=6 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2.5 mg BI 894999
n=13 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2.5 mg of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule C: 5/2.5 mg BI 894999
n=4 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 5 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: 6/3 mg BI 894999
n=15 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: 7/3.5 mg BI 894999
n=12 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 7 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 3.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule B: 1.5 mg BI 894999 (DLBCL Patients)
n=8 Participants
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2 mg BI 894999 (DLBCL Patients)
n=4 Participants
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2.5 mg BI 894999 (DLBCL Patients)
n=2 Participants
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 2.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule C: 4/2 mg BI 894999 (DLBCL Patients)
n=2 Participants
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 4 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: BI 894999 5/2.5 mg (DLBCL Patients)
n=2 Participants
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 5 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2.5 mg of BI 894999, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ib - Schedule B: 2 or 2.5 mg BI 894999 (SCLC Patients)
n=12 Participants
This arm included adult patients diagnosed with small cell lung cancer (SCLC). SCLC patients were initialy administered 2.5 mg of BI 894999. BI 894999 administration was performed in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water according to Schedule B (continuous intake for 14 days followed by one week off treatment in cycles of 21 days).
The Data Monitoring Committee decided on 28 November 2018 to lower the 2.5 mg BI 894999 dose due to safety concerns to 2mg, therefore patients treated before the decision were administered 2.5mg, and patients treated after the decision were administered 2mg.
|
Phase Ib - Schedule B: 2.5 mg BI 894999 (CRC Patients)
n=14 Participants
Adult patients diagnosed with colorectal cancer (CRC) were administered orally 2.5 milligram (mg) of BI 894999. BI 894999 administration was performed in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water according to Schedule B (continuous intake for 14 days followed by one week off treatment in cycles of 21 days).
|
Phase Ib - Schedule B: 2 or 2.5 mg BI 894999 (mCRPC Patients)
n=11 Participants
This arm included adult patients diagnosed with metastatic castrate resistant prostate cancer (mCRPC).
MCRPC patients were initialy administered 2.5 mg of BI 894999. BI 894999 administration was performed in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water according to Schedule B (continuous intake for 14 days followed by one week off treatment in cycles of 21 days).
The Data Monitoring Committee decided on 28 November 2018 to lower the 2.5 mg BI 894999 dose due to safety concerns to 2mg, therefore patients treated before the decision were administered 2.5mg, and patients treated after the decision were administered 2mg.
|
Phase Ib - Schedule B: 2.5 mg BI 894999 (NC Patients)
n=20 Participants
Adult patients diagnosed with NUT carcinoma (NC) were administered orally 2.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days. The 2.5 mg dose could be reduced to 2 mg in case of adverse events.
|
Phase Ib - Schedule C: 6/3 or 7/3.5 mg BI 894999 (NC Patients)
n=22 Participants
This arm included adult patients diagnosed with NUT carcinoma (NC). The DMC reclaimed the maximum tolerated dose (MTD) as 6/3mg on 08 July 2020 after 1 patient was already treated with 7/3.5mg, so the first patient in NC and all the following patients were treated with 6/3mg.
Patients in were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C).
|
Total
n=174 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
69.5 Years
STANDARD_DEVIATION 2.1 • n=7 Participants
|
63.5 Years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
46.7 Years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
57.5 Years
STANDARD_DEVIATION 11.9 • n=4 Participants
|
53.5 Years
STANDARD_DEVIATION 18.1 • n=21 Participants
|
54.5 Years
STANDARD_DEVIATION 26.2 • n=10 Participants
|
60.7 Years
STANDARD_DEVIATION 10.8 • n=115 Participants
|
61.5 Years
STANDARD_DEVIATION 13.0 • n=24 Participants
|
64.5 Years
STANDARD_DEVIATION 7.5 • n=42 Participants
|
63.3 Years
STANDARD_DEVIATION 12.8 • n=42 Participants
|
59.7 Years
STANDARD_DEVIATION 12.0 • n=42 Participants
|
62.5 Years
STANDARD_DEVIATION 6.5 • n=42 Participants
|
71.4 Years
STANDARD_DEVIATION 10.9 • n=36 Participants
|
78.8 Years
STANDARD_DEVIATION 9.0 • n=36 Participants
|
68.5 Years
STANDARD_DEVIATION 2.1 • n=24 Participants
|
68.5 Years
STANDARD_DEVIATION 2.1 • n=135 Participants
|
79.0 Years
STANDARD_DEVIATION 9.9 • n=136 Participants
|
63.5 Years
STANDARD_DEVIATION 7.3 • n=44 Participants
|
66.2 Years
STANDARD_DEVIATION 6.3 • n=667 Participants
|
69.7 Years
STANDARD_DEVIATION 4.1 • n=7 Participants
|
44.4 Years
STANDARD_DEVIATION 13.9 • n=6 Participants
|
40.5 Years
STANDARD_DEVIATION 16.5 • n=10 Participants
|
58.6 Years
STANDARD_DEVIATION 15.2 • n=14 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
5 Participants
n=44 Participants
|
6 Participants
n=667 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=6 Participants
|
8 Participants
n=10 Participants
|
61 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
5 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
7 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
7 Participants
n=44 Participants
|
8 Participants
n=667 Participants
|
11 Participants
n=7 Participants
|
15 Participants
n=6 Participants
|
14 Participants
n=10 Participants
|
113 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
1 Participants
n=667 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=10 Participants
|
6 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
6 Participants
n=24 Participants
|
13 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
14 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
4 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
8 Participants
n=44 Participants
|
8 Participants
n=667 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=6 Participants
|
17 Participants
n=10 Participants
|
143 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
6 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
4 Participants
n=44 Participants
|
5 Participants
n=667 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=6 Participants
|
4 Participants
n=10 Participants
|
25 Participants
n=14 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=6 Participants
|
1 Participants
n=10 Participants
|
4 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=14 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
6 Participants
n=24 Participants
|
13 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
15 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
4 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
7 Participants
n=44 Participants
|
9 Participants
n=667 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=6 Participants
|
16 Participants
n=10 Participants
|
140 Participants
n=14 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
6 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
2 Participants
n=136 Participants
|
4 Participants
n=44 Participants
|
5 Participants
n=667 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=6 Participants
|
4 Participants
n=10 Participants
|
27 Participants
n=14 Participants
|
PRIMARY outcome
Timeframe: First treatment cycle (the first 21 days for Schedules A and B, the first 28 days for Schedule C).Population: Maximum Tolerated Dose (MTD) Evaluation Set (MTDS): Included all patients in the treated set (TS) of Phase 1a who were not replaced for the MTD determination.
Number of patients with Dose Limiting Toxicities (DLTs) observed in the first treatment cycle of Phase Ia is reported. The following drug related adverse events (AEs) qualified as DLT: * any Common Terminology Criteria for Adverse Events (CTCAE) grade ≥3 non haematological toxicity considered related to trial medication with the following exceptions: * inadequately treated nausea, vomiting or diarrhoea. For fatigue, if present at baseline, there had to be an increase of ≥2 grades * electrolytes abnormalities that were corrected within 72 hours with treatment * any haematologic AE related to the trial medication defined as follows: * CTCAE grade ≥4 neutropenia lasting ≥ 7 days and/or complicated by infection, or * CTCAE grade ≥4 thrombocytopenia, or * CTCAE grade≥ 3 thrombocytopenia coupled with grade ≥ 2 of bleeding, or * febrile neutropenia CTCAE grade 3 or higher. * any other drug-related AE preventing the patient from taking his treatment according to the given schedule.
Outcome measures
| Measure |
Phase Ia - Schedule A: 0.2 mg BI 894999
n=2 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 0.2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 0.5 mg BI 894999
n=2 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 0.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 1 mg BI 894999
n=3 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 1 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 1.5 mg BI 894999
n=6 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 2 mg BI 894999
n=6 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 5 mg BI 894999
n=2 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule B: 1.5 mg BI 894999
n=5 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2 mg BI 894999
n=6 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2.5 mg BI 894999
n=12 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2.5 mg of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule C: 5/2.5 mg BI 894999
n=3 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 5 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: 6/3 mg BI 894999
n=12 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: 7/3.5 mg BI 894999
n=10 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 7 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 3.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule B: 1.5 mg BI 894999 (DLBCL Patients)
n=8 Participants
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2 mg BI 894999 (DLBCL Patients)
n=3 Participants
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2.5 mg BI 894999 (DLBCL Patients)
n=2 Participants
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 2.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule C: 4/2 mg BI 894999 (DLBCL Patients)
n=2 Participants
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 4 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: BI 894999 5/2.5 mg (DLBCL Patients)
n=2 Participants
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 5 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2.5 mg of BI 894999, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ib - Schedule C: BI 894999 7/3.5 mg (NC Patients)
Adult patients diagnosed with NUT carcinoma (NC) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 7 milligram (mg) of BI 894999, followed by six days intake of the maintenance dose of 3.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ib - Schedule B: BI 894999 2 mg (Solid Tumours Including NC)
Adult patients diagnosed with one of the following cancer types small cell lung cancer (SCLC); metastatic castrate resistant prostate cancer (mCRPC); NUT carcinoma (NC) were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ib - Schedule B: 2.5 mg BI 894999 (NC Patients)
Adult patients diagnosed with NUT carcinoma (NC) were administered orally 2.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days. The 2.5 mg dose could be reduced to 2 mg in case of adverse events.
|
Phase Ib - Schedule B: BI 894999 2.5 mg (Solid Tumours Including NC)
Adult patients diagnosed with one of the following cancer types small cell lung cancer (SCLC); metastatic castrate resistant prostate cancer (mCRPC); colorectal cancer (CRC); NUT carcinoma (NC) were administered orally 2.5 milligram (mg) of BI 894999, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ib - Schedule C: BI 894999 6/3 mg (NC Patients)
Adult patients diagnosed with NUT carcinoma (NC) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C).
|
Phase Ib - Schedule C: BI 894999 6/3 mg (NC Patients)
Adult patients diagnosed with NUT carcinoma (NC) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase Ia: Number of Patients With DLTs Observed in the First Cycle
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Date of the first administration of study treatment until date of the last administration of study treatment + 30 days residual effect period, up to 883 days.Population: For Phase Ib - Schedule B SCLC, Phase Ib - Schedule B mCRPC, DMC decided on 28Nov2018 to lower the dose of SCLC and mCRPC due to safety concern, thus patients treated prior the decision received 2.5mg BI 894999 and patients treated after the decision received 2mg. For Phase Ib - Schedule C NC, the dose was lowered since DMC reclaimed the MTD as 6/3mg on 08Jul2020 after 1 patient already treated with 7/3.5mg, so the first patient in NC and all the following patients were treated with 6/3mg.
Number of patients with Dose Limiting Toxicities (DLTs) observed during the on-treatment period of Phase Ib is reported. The following drug related adverse events (AEs) qualified as DLT: * any Common Terminology Criteria for Adverse Events (CTCAE) grade ≥3 non haematological toxicity considered related to trial medication with the following exceptions: * inadequately treated nausea, vomiting or diarrhoea. For fatigue, if present at baseline, there had to be an increase of ≥2 grades * electrolytes abnormalities that were corrected within 72 hours with treatment * any haematologic AE related to the trial medication defined as follows: * CTCAE grade ≥4 neutropenia lasting ≥ 7 days and/or complicated by infection, or * CTCAE grade ≥4 thrombocytopenia, or * CTCAE grade≥ 3 thrombocytopenia coupled with grade ≥ 2 of bleeding, or * febrile neutropenia CTCAE grade 3 or higher. * any other drug-related AE preventing the patient from taking his treatment according to the given schedule.
Outcome measures
| Measure |
Phase Ia - Schedule A: 0.2 mg BI 894999
n=12 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 0.2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 0.5 mg BI 894999
n=14 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 0.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 1 mg BI 894999
n=11 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 1 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 1.5 mg BI 894999
n=20 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 2 mg BI 894999
n=22 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 5 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule B: 1.5 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2.5 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2.5 mg of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule C: 5/2.5 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 5 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: 6/3 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: 7/3.5 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 7 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 3.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule B: 1.5 mg BI 894999 (DLBCL Patients)
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2 mg BI 894999 (DLBCL Patients)
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2.5 mg BI 894999 (DLBCL Patients)
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 2.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule C: 4/2 mg BI 894999 (DLBCL Patients)
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 4 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: BI 894999 5/2.5 mg (DLBCL Patients)
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 5 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2.5 mg of BI 894999, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ib - Schedule C: BI 894999 7/3.5 mg (NC Patients)
Adult patients diagnosed with NUT carcinoma (NC) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 7 milligram (mg) of BI 894999, followed by six days intake of the maintenance dose of 3.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ib - Schedule B: BI 894999 2 mg (Solid Tumours Including NC)
Adult patients diagnosed with one of the following cancer types small cell lung cancer (SCLC); metastatic castrate resistant prostate cancer (mCRPC); NUT carcinoma (NC) were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ib - Schedule B: 2.5 mg BI 894999 (NC Patients)
Adult patients diagnosed with NUT carcinoma (NC) were administered orally 2.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days. The 2.5 mg dose could be reduced to 2 mg in case of adverse events.
|
Phase Ib - Schedule B: BI 894999 2.5 mg (Solid Tumours Including NC)
Adult patients diagnosed with one of the following cancer types small cell lung cancer (SCLC); metastatic castrate resistant prostate cancer (mCRPC); colorectal cancer (CRC); NUT carcinoma (NC) were administered orally 2.5 milligram (mg) of BI 894999, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ib - Schedule C: BI 894999 6/3 mg (NC Patients)
Adult patients diagnosed with NUT carcinoma (NC) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C).
|
Phase Ib - Schedule C: BI 894999 6/3 mg (NC Patients)
Adult patients diagnosed with NUT carcinoma (NC) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase Ib: Number of Patients With DLTs Observed During the On-treatment Period
|
3 Participants
|
2 Participants
|
7 Participants
|
2 Participants
|
3 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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—
|
SECONDARY outcome
Timeframe: Date of the first administration of study treatment until date of the last administration of study treatment + 30 days residual effect period, up to 463 days.Population: Included all patients in Phase 1a who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
Number of patients with DLTs observed during the on-treatment period of Phase Ia is reported. The following drug related adverse events (AEs) qualified as DLT: * any Common Terminology Criteria for Adverse Events (CTCAE) grade ≥3 non haematological toxicity considered related to trial medication with the following exceptions: * inadequately treated nausea, vomiting or diarrhoea. For fatigue, if present at baseline, there had to be an increase of ≥2 grades * electrolytes abnormalities that were corrected within 72 hours with treatment * any haematologic AE related to the trial medication defined as follows: * CTCAE grade ≥4 neutropenia lasting ≥ 7 days and/or complicated by infection, or * CTCAE grade ≥4 thrombocytopenia, or * CTCAE grade≥ 3 thrombocytopenia coupled with grade ≥ 2 of bleeding, or * febrile neutropenia CTCAE grade 3 or higher. * any other drug-related AE preventing the patient from taking his treatment according to the given schedule.
Outcome measures
| Measure |
Phase Ia - Schedule A: 0.2 mg BI 894999
n=2 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 0.2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 0.5 mg BI 894999
n=2 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 0.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 1 mg BI 894999
n=3 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 1 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 1.5 mg BI 894999
n=6 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 2 mg BI 894999
n=6 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 5 mg BI 894999
n=2 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule B: 1.5 mg BI 894999
n=6 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2 mg BI 894999
n=6 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2.5 mg BI 894999
n=13 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2.5 mg of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule C: 5/2.5 mg BI 894999
n=4 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 5 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: 6/3 mg BI 894999
n=15 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: 7/3.5 mg BI 894999
n=12 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 7 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 3.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule B: 1.5 mg BI 894999 (DLBCL Patients)
n=8 Participants
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2 mg BI 894999 (DLBCL Patients)
n=4 Participants
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2.5 mg BI 894999 (DLBCL Patients)
n=2 Participants
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 2.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule C: 4/2 mg BI 894999 (DLBCL Patients)
n=2 Participants
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 4 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: BI 894999 5/2.5 mg (DLBCL Patients)
n=2 Participants
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 5 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2.5 mg of BI 894999, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ib - Schedule C: BI 894999 7/3.5 mg (NC Patients)
Adult patients diagnosed with NUT carcinoma (NC) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 7 milligram (mg) of BI 894999, followed by six days intake of the maintenance dose of 3.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ib - Schedule B: BI 894999 2 mg (Solid Tumours Including NC)
Adult patients diagnosed with one of the following cancer types small cell lung cancer (SCLC); metastatic castrate resistant prostate cancer (mCRPC); NUT carcinoma (NC) were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ib - Schedule B: 2.5 mg BI 894999 (NC Patients)
Adult patients diagnosed with NUT carcinoma (NC) were administered orally 2.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days. The 2.5 mg dose could be reduced to 2 mg in case of adverse events.
|
Phase Ib - Schedule B: BI 894999 2.5 mg (Solid Tumours Including NC)
Adult patients diagnosed with one of the following cancer types small cell lung cancer (SCLC); metastatic castrate resistant prostate cancer (mCRPC); colorectal cancer (CRC); NUT carcinoma (NC) were administered orally 2.5 milligram (mg) of BI 894999, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ib - Schedule C: BI 894999 6/3 mg (NC Patients)
Adult patients diagnosed with NUT carcinoma (NC) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C).
|
Phase Ib - Schedule C: BI 894999 6/3 mg (NC Patients)
Adult patients diagnosed with NUT carcinoma (NC) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase Ia: Number of Patients With DLTs Observed During the On-treatment Period
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 minutes (min) before and at 30 min, 1 hour (h), 2h, 3h, 4h, 6h, 8h and 23h55min after administration of first BI 894999 dose on Day 1 of Cycle 1.Population: Pharmacokinetic (PK) analysis Set (PKS): Included all patients in the treated set (TS) who have at least one evaluable PK parameters. In phase Ib, solid tumor patients (SCLC, mCRPC, CRC and NC) are combined by dose level (2 or 2.5mg) as data of all solid tumor patients were needed since no differences were expected, but the NC patients alone were differentiated in an additional subgroup as it was the initial indication for BI 894999.
Area under the concentration-time curve of BI 894999 in plasma over the time interval from 0 to 24 hours after administration of the first dose (AUC0-24) for Phase Ia and Phase Ib is reported.
Outcome measures
| Measure |
Phase Ia - Schedule A: 0.2 mg BI 894999
n=2 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 0.2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 0.5 mg BI 894999
n=2 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 0.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 1 mg BI 894999
n=3 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 1 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 1.5 mg BI 894999
n=5 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 2 mg BI 894999
n=4 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 5 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule B: 1.5 mg BI 894999
n=3 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2 mg BI 894999
n=4 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2.5 mg BI 894999
n=11 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2.5 mg of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule C: 5/2.5 mg BI 894999
n=4 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 5 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: 6/3 mg BI 894999
n=15 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: 7/3.5 mg BI 894999
n=12 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 7 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 3.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule B: 1.5 mg BI 894999 (DLBCL Patients)
n=7 Participants
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2 mg BI 894999 (DLBCL Patients)
n=4 Participants
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2.5 mg BI 894999 (DLBCL Patients)
n=2 Participants
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 2.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule C: 4/2 mg BI 894999 (DLBCL Patients)
n=2 Participants
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 4 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: BI 894999 5/2.5 mg (DLBCL Patients)
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 5 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2.5 mg of BI 894999, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ib - Schedule C: BI 894999 7/3.5 mg (NC Patients)
n=1 Participants
Adult patients diagnosed with NUT carcinoma (NC) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 7 milligram (mg) of BI 894999, followed by six days intake of the maintenance dose of 3.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ib - Schedule B: BI 894999 2 mg (Solid Tumours Including NC)
n=9 Participants
Adult patients diagnosed with one of the following cancer types small cell lung cancer (SCLC); metastatic castrate resistant prostate cancer (mCRPC); NUT carcinoma (NC) were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ib - Schedule B: 2.5 mg BI 894999 (NC Patients)
n=17 Participants
Adult patients diagnosed with NUT carcinoma (NC) were administered orally 2.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days. The 2.5 mg dose could be reduced to 2 mg in case of adverse events.
|
Phase Ib - Schedule B: BI 894999 2.5 mg (Solid Tumours Including NC)
n=42 Participants
Adult patients diagnosed with one of the following cancer types small cell lung cancer (SCLC); metastatic castrate resistant prostate cancer (mCRPC); colorectal cancer (CRC); NUT carcinoma (NC) were administered orally 2.5 milligram (mg) of BI 894999, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ib - Schedule C: BI 894999 6/3 mg (NC Patients)
n=2 Participants
Adult patients diagnosed with NUT carcinoma (NC) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C).
|
Phase Ib - Schedule C: BI 894999 6/3 mg (NC Patients)
Adult patients diagnosed with NUT carcinoma (NC) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase Ia and Phase Ib: Area Under the Concentration-time Curve of BI 894999 in Plasma Over the Time Interval From 0 to 24 Hours After Administration of the First Dose (AUC0-24)
|
4.36 nanomole * hour /Liter (nmol*h/L)
Geometric Coefficient of Variation 21.1
|
6.43 nanomole * hour /Liter (nmol*h/L)
Geometric Coefficient of Variation 2.78
|
20.5 nanomole * hour /Liter (nmol*h/L)
Geometric Coefficient of Variation 16.8
|
34.0 nanomole * hour /Liter (nmol*h/L)
Geometric Coefficient of Variation 69.4
|
64.9 nanomole * hour /Liter (nmol*h/L)
Geometric Coefficient of Variation 71.0
|
—
|
27.7 nanomole * hour /Liter (nmol*h/L)
Geometric Coefficient of Variation 81.5
|
44.8 nanomole * hour /Liter (nmol*h/L)
Geometric Coefficient of Variation 34.8
|
51.5 nanomole * hour /Liter (nmol*h/L)
Geometric Coefficient of Variation 41.7
|
123 nanomole * hour /Liter (nmol*h/L)
Geometric Coefficient of Variation 37.6
|
212 nanomole * hour /Liter (nmol*h/L)
Geometric Coefficient of Variation 45.5
|
230 nanomole * hour /Liter (nmol*h/L)
Geometric Coefficient of Variation 27.3
|
31.7 nanomole * hour /Liter (nmol*h/L)
Geometric Coefficient of Variation 33.4
|
48.0 nanomole * hour /Liter (nmol*h/L)
Geometric Coefficient of Variation 26.9
|
53.3 nanomole * hour /Liter (nmol*h/L)
Geometric Coefficient of Variation 6.91
|
138 nanomole * hour /Liter (nmol*h/L)
Geometric Coefficient of Variation 7.52
|
—
|
NA nanomole * hour /Liter (nmol*h/L)
Geometric Coefficient of Variation NA
AUC0-24 could not be provided to reduce the risk of patient re-identificaton.
|
39.2 nanomole * hour /Liter (nmol*h/L)
Geometric Coefficient of Variation 38.8
|
56.9 nanomole * hour /Liter (nmol*h/L)
Geometric Coefficient of Variation 58.6
|
67.6 nanomole * hour /Liter (nmol*h/L)
Geometric Coefficient of Variation 50.9
|
214 nanomole * hour /Liter (nmol*h/L)
Geometric Coefficient of Variation 6.01
|
—
|
SECONDARY outcome
Timeframe: 5 minutes (min) before and at 30 min, 1 hour (h), 2h, 3h, 4h, 6h, 8h and 23h55min after administration of first BI 894999 dose on Day 1 of Cycle 1.Population: Pharmacokinetic (PK) analysis Set (PKS): Included all patients in the treated set (TS) who have at least one evaluable PK parameters. In phase Ib, solid tumor patients (SCLC, mCRPC, CRC and NC) are combined by dose level (2 or 2.5mg) as data of all solid tumor patients were needed since no differences were expected, but the NC patients alone were differentiated in an additional subgroup as it was the initial indication for BI894999.
Maximum measured concentration of BI 894999 in plasma after the first dose (Cmax) for Phase 1a and Phase 1b is reported.
Outcome measures
| Measure |
Phase Ia - Schedule A: 0.2 mg BI 894999
n=2 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 0.2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 0.5 mg BI 894999
n=2 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 0.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 1 mg BI 894999
n=3 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 1 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 1.5 mg BI 894999
n=5 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 2 mg BI 894999
n=4 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 5 mg BI 894999
n=2 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule B: 1.5 mg BI 894999
n=3 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2 mg BI 894999
n=4 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2.5 mg BI 894999
n=11 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2.5 mg of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule C: 5/2.5 mg BI 894999
n=4 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 5 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: 6/3 mg BI 894999
n=15 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: 7/3.5 mg BI 894999
n=12 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 7 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 3.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule B: 1.5 mg BI 894999 (DLBCL Patients)
n=7 Participants
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2 mg BI 894999 (DLBCL Patients)
n=4 Participants
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2.5 mg BI 894999 (DLBCL Patients)
n=2 Participants
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 2.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule C: 4/2 mg BI 894999 (DLBCL Patients)
n=2 Participants
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 4 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: BI 894999 5/2.5 mg (DLBCL Patients)
n=1 Participants
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 5 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2.5 mg of BI 894999, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ib - Schedule C: BI 894999 7/3.5 mg (NC Patients)
n=1 Participants
Adult patients diagnosed with NUT carcinoma (NC) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 7 milligram (mg) of BI 894999, followed by six days intake of the maintenance dose of 3.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ib - Schedule B: BI 894999 2 mg (Solid Tumours Including NC)
n=9 Participants
Adult patients diagnosed with one of the following cancer types small cell lung cancer (SCLC); metastatic castrate resistant prostate cancer (mCRPC); NUT carcinoma (NC) were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ib - Schedule B: 2.5 mg BI 894999 (NC Patients)
n=17 Participants
Adult patients diagnosed with NUT carcinoma (NC) were administered orally 2.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days. The 2.5 mg dose could be reduced to 2 mg in case of adverse events.
|
Phase Ib - Schedule B: BI 894999 2.5 mg (Solid Tumours Including NC)
n=44 Participants
Adult patients diagnosed with one of the following cancer types small cell lung cancer (SCLC); metastatic castrate resistant prostate cancer (mCRPC); colorectal cancer (CRC); NUT carcinoma (NC) were administered orally 2.5 milligram (mg) of BI 894999, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ib - Schedule C: BI 894999 6/3 mg (NC Patients)
n=15 Participants
Adult patients diagnosed with NUT carcinoma (NC) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C).
|
Phase Ib - Schedule C: BI 894999 6/3 mg (NC Patients)
Adult patients diagnosed with NUT carcinoma (NC) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase Ia and Phase Ib: Maximum Measured Concentration of BI 894999 in Plasma After the First Dose (Cmax)
|
0.393 nanomole/L (nmol/L)
Geometric Coefficient of Variation 35.6
|
0.569 nanomole/L (nmol/L)
Geometric Coefficient of Variation 46.2
|
1.75 nanomole/L (nmol/L)
Geometric Coefficient of Variation 31.6
|
3.79 nanomole/L (nmol/L)
Geometric Coefficient of Variation 84.0
|
7.39 nanomole/L (nmol/L)
Geometric Coefficient of Variation 56.0
|
16.2 nanomole/L (nmol/L)
Geometric Coefficient of Variation 68.0
|
3.00 nanomole/L (nmol/L)
Geometric Coefficient of Variation 155
|
3.93 nanomole/L (nmol/L)
Geometric Coefficient of Variation 50.2
|
4.48 nanomole/L (nmol/L)
Geometric Coefficient of Variation 46.6
|
12.0 nanomole/L (nmol/L)
Geometric Coefficient of Variation 85.1
|
19.4 nanomole/L (nmol/L)
Geometric Coefficient of Variation 58.4
|
21.0 nanomole/L (nmol/L)
Geometric Coefficient of Variation 48.3
|
2.98 nanomole/L (nmol/L)
Geometric Coefficient of Variation 34.9
|
4.49 nanomole/L (nmol/L)
Geometric Coefficient of Variation 36.0
|
4.75 nanomole/L (nmol/L)
Geometric Coefficient of Variation 0.595
|
13.9 nanomole/L (nmol/L)
Geometric Coefficient of Variation 12.8
|
NA nanomole/L (nmol/L)
Geometric Coefficient of Variation NA
Cmax could not be provided to reduce the risk of patient re-identificaton.
|
NA nanomole/L (nmol/L)
Geometric Coefficient of Variation NA
Cmax could not be provided to reduce the risk of patient re-identificaton.
|
4.10 nanomole/L (nmol/L)
Geometric Coefficient of Variation 37.8
|
4.88 nanomole/L (nmol/L)
Geometric Coefficient of Variation 50.1
|
6.01 nanomole/L (nmol/L)
Geometric Coefficient of Variation 59.6
|
18.8 nanomole/L (nmol/L)
Geometric Coefficient of Variation 55.8
|
—
|
SECONDARY outcome
Timeframe: 5 minutes (min) before and at 30 min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, and at 23h55min (Schedule A) or 24h (Schedule B & C) following administration on day 14 (Schedule A & B) or day 21 (Schedule C).Population: Pharmacokinetic (PK) analysis Set (PKS): Included all patients in the treated set (TS) who have at least one evaluable PK parameters. In phase Ib, solid tumor patients (SCLC, mCRPC, CRC and NC) are combined by dose level (2 or 2.5mg) as data of all solid tumor patients were needed since no differences were expected, but the NC patients alone were differentiated in an additional subgroup as it was the initial indication for BI 894999.
Area under the concentration-time curve of BI 894999 in plasma at steady state over a uniform dosing interval τ (AUCτ, ss) for Phase Ia and Ib is reported. The dosing interval is 24 hours (h) for all dose groups.
Outcome measures
| Measure |
Phase Ia - Schedule A: 0.2 mg BI 894999
n=2 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 0.2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 0.5 mg BI 894999
n=2 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 0.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 1 mg BI 894999
n=3 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 1 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 1.5 mg BI 894999
n=4 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 2 mg BI 894999
n=4 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 5 mg BI 894999
n=1 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule B: 1.5 mg BI 894999
n=4 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2 mg BI 894999
n=6 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2.5 mg BI 894999
n=11 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2.5 mg of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule C: 5/2.5 mg BI 894999
n=3 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 5 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: 6/3 mg BI 894999
n=14 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: 7/3.5 mg BI 894999
n=5 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 7 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 3.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule B: 1.5 mg BI 894999 (DLBCL Patients)
n=6 Participants
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2 mg BI 894999 (DLBCL Patients)
n=3 Participants
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2.5 mg BI 894999 (DLBCL Patients)
n=1 Participants
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 2.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule C: 4/2 mg BI 894999 (DLBCL Patients)
n=1 Participants
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 4 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: BI 894999 5/2.5 mg (DLBCL Patients)
n=1 Participants
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 5 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2.5 mg of BI 894999, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ib - Schedule C: BI 894999 7/3.5 mg (NC Patients)
Adult patients diagnosed with NUT carcinoma (NC) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 7 milligram (mg) of BI 894999, followed by six days intake of the maintenance dose of 3.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ib - Schedule B: BI 894999 2 mg (Solid Tumours Including NC)
n=1 Participants
Adult patients diagnosed with one of the following cancer types small cell lung cancer (SCLC); metastatic castrate resistant prostate cancer (mCRPC); NUT carcinoma (NC) were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ib - Schedule B: 2.5 mg BI 894999 (NC Patients)
n=10 Participants
Adult patients diagnosed with NUT carcinoma (NC) were administered orally 2.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days. The 2.5 mg dose could be reduced to 2 mg in case of adverse events.
|
Phase Ib - Schedule B: BI 894999 2.5 mg (Solid Tumours Including NC)
n=14 Participants
Adult patients diagnosed with one of the following cancer types small cell lung cancer (SCLC); metastatic castrate resistant prostate cancer (mCRPC); colorectal cancer (CRC); NUT carcinoma (NC) were administered orally 2.5 milligram (mg) of BI 894999, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ib - Schedule C: BI 894999 6/3 mg (NC Patients)
n=33 Participants
Adult patients diagnosed with NUT carcinoma (NC) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C).
|
Phase Ib - Schedule C: BI 894999 6/3 mg (NC Patients)
n=11 Participants
Adult patients diagnosed with NUT carcinoma (NC) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase Ia and Phase Ib: Area Under the Concentration-time Curve of BI 894999 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ, ss)
|
10.3 nanomole *hour/Liter (nmol*h/)L
Geometric Coefficient of Variation 72.6
|
17.9 nanomole *hour/Liter (nmol*h/)L
Geometric Coefficient of Variation 46.4
|
54.6 nanomole *hour/Liter (nmol*h/)L
Geometric Coefficient of Variation 40.4
|
76.4 nanomole *hour/Liter (nmol*h/)L
Geometric Coefficient of Variation 26.6
|
119 nanomole *hour/Liter (nmol*h/)L
Geometric Coefficient of Variation 90.3
|
NA nanomole *hour/Liter (nmol*h/)L
Geometric Coefficient of Variation NA
AUCτ, ss could not be provided to reduce the risk of patient re-identificaton.
|
62.6 nanomole *hour/Liter (nmol*h/)L
Geometric Coefficient of Variation 49.2
|
81.1 nanomole *hour/Liter (nmol*h/)L
Geometric Coefficient of Variation 32.1
|
87.0 nanomole *hour/Liter (nmol*h/)L
Geometric Coefficient of Variation 28.3
|
144 nanomole *hour/Liter (nmol*h/)L
Geometric Coefficient of Variation 46.4
|
176 nanomole *hour/Liter (nmol*h/)L
Geometric Coefficient of Variation 37.0
|
226 nanomole *hour/Liter (nmol*h/)L
Geometric Coefficient of Variation 63.2
|
70.3 nanomole *hour/Liter (nmol*h/)L
Geometric Coefficient of Variation 38.5
|
120 nanomole *hour/Liter (nmol*h/)L
Geometric Coefficient of Variation 19.6
|
NA nanomole *hour/Liter (nmol*h/)L
Geometric Coefficient of Variation NA
AUCτ, ss could not be provided to reduce the risk of patient re-identificaton.
|
NA nanomole *hour/Liter (nmol*h/)L
Geometric Coefficient of Variation NA
AUCτ, ss could not be provided to reduce the risk of patient re-identificaton.
|
NA nanomole *hour/Liter (nmol*h/)L
Geometric Coefficient of Variation NA
AUCτ, ss could not be provided to reduce the risk of patient re-identificaton.
|
—
|
NA nanomole *hour/Liter (nmol*h/)L
Geometric Coefficient of Variation NA
AUCτ, ss could not be provided to reduce the risk of patient re-identificaton.
|
73.6 nanomole *hour/Liter (nmol*h/)L
Geometric Coefficient of Variation 58.2
|
94.9 nanomole *hour/Liter (nmol*h/)L
Geometric Coefficient of Variation 43.9
|
125 nanomole *hour/Liter (nmol*h/)L
Geometric Coefficient of Variation 50.4
|
149 nanomole *hour/Liter (nmol*h/)L
Geometric Coefficient of Variation 56.7
|
SECONDARY outcome
Timeframe: 5 minutes (min) before and at 30 min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, and at 23h55min (Schedule A) or 24h (Schedule B & C) following administration on day 14 (Schedule A & B) or day 21 (Schedule C).Population: Pharmacokinetic (PK) analysis Set (PKS): Included all patients in the treated set (TS) who have at least one evaluable PK parameters. In phase Ib, solid tumor patients (SCLC, mCRPC, CRC and NC) are combined by dose level (2 or 2.5mg) as data of all solid tumor patients were needed since no differences were expected, but the NC patients alone were differentiated in an additional subgroup as it was the initial indication for BI894999.
Maximum measured concentration of BI 894999 in plasma at steady state over a uniform dosing interval τ (Cmax, ss) for Phase Ia and Phase Ib is reported. The dosing interval is 24 hours (h) for all dose groups.
Outcome measures
| Measure |
Phase Ia - Schedule A: 0.2 mg BI 894999
n=2 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 0.2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 0.5 mg BI 894999
n=2 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 0.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 1 mg BI 894999
n=3 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 1 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 1.5 mg BI 894999
n=6 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 2 mg BI 894999
n=6 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 5 mg BI 894999
n=1 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule B: 1.5 mg BI 894999
n=4 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2 mg BI 894999
n=6 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2.5 mg BI 894999
n=11 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2.5 mg of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule C: 5/2.5 mg BI 894999
n=3 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 5 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: 6/3 mg BI 894999
n=14 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: 7/3.5 mg BI 894999
n=5 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 7 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 3.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule B: 1.5 mg BI 894999 (DLBCL Patients)
n=6 Participants
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2 mg BI 894999 (DLBCL Patients)
n=3 Participants
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2.5 mg BI 894999 (DLBCL Patients)
n=1 Participants
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 2.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule C: 4/2 mg BI 894999 (DLBCL Patients)
n=1 Participants
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 4 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: BI 894999 5/2.5 mg (DLBCL Patients)
n=1 Participants
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 5 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2.5 mg of BI 894999, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ib - Schedule C: BI 894999 7/3.5 mg (NC Patients)
Adult patients diagnosed with NUT carcinoma (NC) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 7 milligram (mg) of BI 894999, followed by six days intake of the maintenance dose of 3.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ib - Schedule B: BI 894999 2 mg (Solid Tumours Including NC)
n=1 Participants
Adult patients diagnosed with one of the following cancer types small cell lung cancer (SCLC); metastatic castrate resistant prostate cancer (mCRPC); NUT carcinoma (NC) were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ib - Schedule B: 2.5 mg BI 894999 (NC Patients)
n=10 Participants
Adult patients diagnosed with NUT carcinoma (NC) were administered orally 2.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days. The 2.5 mg dose could be reduced to 2 mg in case of adverse events.
|
Phase Ib - Schedule B: BI 894999 2.5 mg (Solid Tumours Including NC)
n=14 Participants
Adult patients diagnosed with one of the following cancer types small cell lung cancer (SCLC); metastatic castrate resistant prostate cancer (mCRPC); colorectal cancer (CRC); NUT carcinoma (NC) were administered orally 2.5 milligram (mg) of BI 894999, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ib - Schedule C: BI 894999 6/3 mg (NC Patients)
n=33 Participants
Adult patients diagnosed with NUT carcinoma (NC) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C).
|
Phase Ib - Schedule C: BI 894999 6/3 mg (NC Patients)
n=11 Participants
Adult patients diagnosed with NUT carcinoma (NC) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase Ia and Phase Ib: Maximum Measured Concentration of BI 894999 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax, ss)
|
0.697 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 59.8
|
1.26 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 24.9
|
4.06 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 61.7
|
5.25 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 60.1
|
11.6 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 54.4
|
NA nanomole/Liter (nmol/L)
Geometric Coefficient of Variation NA
Cmax, ss could not be provided to reduce the risk of patient re-identificaton.
|
4.75 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 46.9
|
5.62 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 27.7
|
6.94 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 42.0
|
11.4 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 56.1
|
13.1 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 41.8
|
17.1 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 63.6
|
5.48 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 32.7
|
7.67 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 8.44
|
NA nanomole/Liter (nmol/L)
Geometric Coefficient of Variation NA
Cmax, ss could not be provided to reduce the risk of patient re-identificaton.
|
NA nanomole/Liter (nmol/L)
Geometric Coefficient of Variation NA
Cmax, ss could not be provided to reduce the risk of patient re-identificaton.
|
NA nanomole/Liter (nmol/L)
Geometric Coefficient of Variation NA
Cmax, ss could not be provided to reduce the risk of patient re-identificaton.
|
—
|
NA nanomole/Liter (nmol/L)
Geometric Coefficient of Variation NA
Cmax, ss could not be provided to reduce the risk of patient re-identificaton.
|
6.51 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 70.0
|
7.68 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 45.4
|
10.4 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 59.4
|
11.2 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 60.1
|
SECONDARY outcome
Timeframe: Up to 15 months for Phase 1a and up to 28 months for Phase Ib.Population: For Phase Ib - Schedule B SCLC, Phase Ib - Schedule B mCRPC, DMC decided on 28Nov2018 to lower the dose of SCLC and mCRPC due to safety concern, thus patients treated prior the decision received 2.5mg BI 894999 and patients treated after the decision received 2mg. For Phase Ib - Schedule C NC, the dose was lowered since DMC reclaimed the MTD as 6/3mg on 08Jul2020 after 1 patient already treated with 7/3.5mg, so the first patient in NC and all the following patients were treated with 6/3mg.
OR was defined as best overall response (BOR) of complete response (CR) or partial response (PR) with tumour assessment during treatment period for each schedule. For DLBCL patients, a minor response according to Response Evaluation Criteria In Lymphoma 2017 (RECIL 2017) was not part of an objective response. BOR was determined from first treatment administration until the earliest of disease progression, death or last evaluable tumour assessment before start of subsequent anticancer therapy, loss to follow-up or withdrawal of consent, according to the following criteria depending on the type of cancer: * solid tumour patients and mCRPC patients with measurable disease: CT and/ or MRI according to RECIST v1.1, every 2 cycles; * mCRPC patients without measurable disease: bone scan and PSA level according to Prostate Cancer Clinical Trials Working Group 3, every 4 cycles; * DLBCL patients:FDG-PET/CT scans according to RECIL 2017; every 2 cycles.
Outcome measures
| Measure |
Phase Ia - Schedule A: 0.2 mg BI 894999
n=2 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 0.2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 0.5 mg BI 894999
n=2 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 0.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 1 mg BI 894999
n=3 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 1 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 1.5 mg BI 894999
n=6 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 2 mg BI 894999
n=6 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 5 mg BI 894999
n=2 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule B: 1.5 mg BI 894999
n=6 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2 mg BI 894999
n=6 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2.5 mg BI 894999
n=13 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2.5 mg of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule C: 5/2.5 mg BI 894999
n=4 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 5 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: 6/3 mg BI 894999
n=15 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: 7/3.5 mg BI 894999
n=12 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 7 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 3.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule B: 1.5 mg BI 894999 (DLBCL Patients)
n=8 Participants
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2 mg BI 894999 (DLBCL Patients)
n=4 Participants
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2.5 mg BI 894999 (DLBCL Patients)
n=2 Participants
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 2.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule C: 4/2 mg BI 894999 (DLBCL Patients)
n=2 Participants
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 4 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: BI 894999 5/2.5 mg (DLBCL Patients)
n=2 Participants
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 5 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2.5 mg of BI 894999, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ib - Schedule C: BI 894999 7/3.5 mg (NC Patients)
n=12 Participants
Adult patients diagnosed with NUT carcinoma (NC) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 7 milligram (mg) of BI 894999, followed by six days intake of the maintenance dose of 3.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ib - Schedule B: BI 894999 2 mg (Solid Tumours Including NC)
n=14 Participants
Adult patients diagnosed with one of the following cancer types small cell lung cancer (SCLC); metastatic castrate resistant prostate cancer (mCRPC); NUT carcinoma (NC) were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ib - Schedule B: 2.5 mg BI 894999 (NC Patients)
n=11 Participants
Adult patients diagnosed with NUT carcinoma (NC) were administered orally 2.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days. The 2.5 mg dose could be reduced to 2 mg in case of adverse events.
|
Phase Ib - Schedule B: BI 894999 2.5 mg (Solid Tumours Including NC)
n=20 Participants
Adult patients diagnosed with one of the following cancer types small cell lung cancer (SCLC); metastatic castrate resistant prostate cancer (mCRPC); colorectal cancer (CRC); NUT carcinoma (NC) were administered orally 2.5 milligram (mg) of BI 894999, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ib - Schedule C: BI 894999 6/3 mg (NC Patients)
n=22 Participants
Adult patients diagnosed with NUT carcinoma (NC) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C).
|
Phase Ib - Schedule C: BI 894999 6/3 mg (NC Patients)
Adult patients diagnosed with NUT carcinoma (NC) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase Ia and Phase Ib: Objective Response (OR)
|
0 Participants
|
1 Participants
|
0 Participants
|
1 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
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 28 months.Population: For Phase Ib - Schedule B SCLC, Phase Ib - Schedule B mCRPC, DMC decided on 28Nov2018 to lower the dose of SCLC and mCRPC due to safety concern, thus patients treated prior the decision received 2.5mg BI 894999 and patients treated after the decision received 2mg. For Phase Ib - Schedule C NC, the dose was lowered since DMC reclaimed the MTD as 6/3mg on 08Jul2020 after 1 patient already treated with 7/3.5mg, so the first patient in NC and all the following patients were treated with 6/3mg.
Progression-free survival (PFS) was defined as the time from date of start of BI 894999 to the date of objective disease progression ((PD) defined as 20% increase in the sum of the longest diameter of target lesions) or death, whichever is earlier for SCLC patients, CRC patients, mCRPC patients with measurable disease by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and NC patients, with tumour assessment every 2 cycles according to RECIST v1.1 during treatment period or Radiological PFS with tumour assessment by bone scan every 4 cycles for mCRPC patients with non-measurable disease by RECIST v1.1. For patients with 'event' as an outcome for PFS: \- PFS \[days\] = date of outcome - date of first treatment administration + 1. For patients with 'censored' as an outcome for PFS: \- PFS (censored) \[days\] = date of outcome - date of first treatment administration + 1. The Kaplan-Meier method was used to calculate the estimates.
Outcome measures
| Measure |
Phase Ia - Schedule A: 0.2 mg BI 894999
n=12 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 0.2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 0.5 mg BI 894999
n=14 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 0.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 1 mg BI 894999
n=11 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 1 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 1.5 mg BI 894999
n=20 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 2 mg BI 894999
n=22 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 5 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule B: 1.5 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2.5 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2.5 mg of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule C: 5/2.5 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 5 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: 6/3 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: 7/3.5 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 7 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 3.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule B: 1.5 mg BI 894999 (DLBCL Patients)
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2 mg BI 894999 (DLBCL Patients)
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2.5 mg BI 894999 (DLBCL Patients)
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 2.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule C: 4/2 mg BI 894999 (DLBCL Patients)
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 4 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: BI 894999 5/2.5 mg (DLBCL Patients)
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 5 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2.5 mg of BI 894999, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ib - Schedule C: BI 894999 7/3.5 mg (NC Patients)
Adult patients diagnosed with NUT carcinoma (NC) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 7 milligram (mg) of BI 894999, followed by six days intake of the maintenance dose of 3.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ib - Schedule B: BI 894999 2 mg (Solid Tumours Including NC)
Adult patients diagnosed with one of the following cancer types small cell lung cancer (SCLC); metastatic castrate resistant prostate cancer (mCRPC); NUT carcinoma (NC) were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ib - Schedule B: 2.5 mg BI 894999 (NC Patients)
Adult patients diagnosed with NUT carcinoma (NC) were administered orally 2.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days. The 2.5 mg dose could be reduced to 2 mg in case of adverse events.
|
Phase Ib - Schedule B: BI 894999 2.5 mg (Solid Tumours Including NC)
Adult patients diagnosed with one of the following cancer types small cell lung cancer (SCLC); metastatic castrate resistant prostate cancer (mCRPC); colorectal cancer (CRC); NUT carcinoma (NC) were administered orally 2.5 milligram (mg) of BI 894999, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ib - Schedule C: BI 894999 6/3 mg (NC Patients)
Adult patients diagnosed with NUT carcinoma (NC) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C).
|
Phase Ib - Schedule C: BI 894999 6/3 mg (NC Patients)
Adult patients diagnosed with NUT carcinoma (NC) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Phase Ib: Progression-free Survival or (PFS) or Radiological PFS for mCRPC Patients With Non-measurable Disease by RECIST v1.1
|
5.6 Weeks
Interval 5.3 to 6.1
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5.6 Weeks
Interval 4.4 to 10.7
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11.9 Weeks
Interval 8.1 to 24.4
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6.9 Weeks
Interval 6.0 to 11.1
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7.8 Weeks
Interval 4.0 to 13.0
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SECONDARY outcome
Timeframe: Imaging and assessment performed every 2 cycles (solid tumours patients) or 4 cycles (mCRPC patients) for the entire treatment period, up to 28 months.Population: For Phase Ib - Schedule B SCLC, Phase Ib - Schedule B mCRPC, DMC decided on 28Nov2018 to lower the dose of SCLC and mCRPC due to safety concern, thus patients treated prior the decision received 2.5mg BI 894999 and patients treated after the decision received 2mg. For Phase Ib - Schedule C NC, the dose was lowered since DMC reclaimed the MTD as 6/3mg on 08Jul2020 after 1 patient already treated with 7/3.5mg, so the first patient in NC and all the following patients were treated with 6/3mg.
Best overall response (BOR) was determined from first treatment administration until the earliest of disease progression, death or last evaluable tumour assessment before start of subsequent anticancer therapy, loss to follow-up or withdrawal of consent, according to the following criteria depending on the type of cancer: * solid tumour patients and mCRPC patients with measurable disease: Computerized tomography (CT) and/ or magnetic resonance imaging (MRI) according to RECIST v1.1, every 2 cycles; * mCRPC patients without measurable disease: bone scan and PSA level according to Prostate Cancer Clinical Trials Working Group 3, every 4 cycles.
Outcome measures
| Measure |
Phase Ia - Schedule A: 0.2 mg BI 894999
n=12 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 0.2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 0.5 mg BI 894999
n=14 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 0.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 1 mg BI 894999
n=11 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 1 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 1.5 mg BI 894999
n=20 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 2 mg BI 894999
n=22 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 5 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule B: 1.5 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2.5 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2.5 mg of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule C: 5/2.5 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 5 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: 6/3 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: 7/3.5 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 7 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 3.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule B: 1.5 mg BI 894999 (DLBCL Patients)
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2 mg BI 894999 (DLBCL Patients)
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2.5 mg BI 894999 (DLBCL Patients)
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 2.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule C: 4/2 mg BI 894999 (DLBCL Patients)
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 4 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: BI 894999 5/2.5 mg (DLBCL Patients)
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 5 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2.5 mg of BI 894999, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ib - Schedule C: BI 894999 7/3.5 mg (NC Patients)
Adult patients diagnosed with NUT carcinoma (NC) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 7 milligram (mg) of BI 894999, followed by six days intake of the maintenance dose of 3.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ib - Schedule B: BI 894999 2 mg (Solid Tumours Including NC)
Adult patients diagnosed with one of the following cancer types small cell lung cancer (SCLC); metastatic castrate resistant prostate cancer (mCRPC); NUT carcinoma (NC) were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ib - Schedule B: 2.5 mg BI 894999 (NC Patients)
Adult patients diagnosed with NUT carcinoma (NC) were administered orally 2.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days. The 2.5 mg dose could be reduced to 2 mg in case of adverse events.
|
Phase Ib - Schedule B: BI 894999 2.5 mg (Solid Tumours Including NC)
Adult patients diagnosed with one of the following cancer types small cell lung cancer (SCLC); metastatic castrate resistant prostate cancer (mCRPC); colorectal cancer (CRC); NUT carcinoma (NC) were administered orally 2.5 milligram (mg) of BI 894999, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ib - Schedule C: BI 894999 6/3 mg (NC Patients)
Adult patients diagnosed with NUT carcinoma (NC) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C).
|
Phase Ib - Schedule C: BI 894999 6/3 mg (NC Patients)
Adult patients diagnosed with NUT carcinoma (NC) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Phase Ib: Best Overall Response
Progressive disease
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8 Participants
|
10 Participants
|
4 Participants
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9 Participants
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9 Participants
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Phase Ib: Best Overall Response
Complete response
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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1 Participants
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Phase Ib: Best Overall Response
Partial response
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0 Participants
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0 Participants
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1 Participants
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1 Participants
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1 Participants
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Phase Ib: Best Overall Response
Stable disease
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1 Participants
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2 Participants
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2 Participants
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7 Participants
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6 Participants
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Phase Ib: Best Overall Response
Not evaluable
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3 Participants
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2 Participants
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4 Participants
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3 Participants
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5 Participants
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Phase Ib: Best Overall Response
Not assessed
|
0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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SECONDARY outcome
Timeframe: Up to 28 months.Population: Patients in NC Schedules B and C in Phase Ib dose expansion and after approval of protocol version 11.0 and gave consent to the collection of overall survival status. For "Phase Ib - Schedule C: 6/3 or 7/3.5 mg BI 894999 (NC patients)" arm, the dose was lowered since DMC reclaimed the MTD as 6/3mg on 08Jul2020 after 1 patient already treated with 7/3.5mg, so the first patient in NC and all the following patients were treated with 6/3mg.
Overall survival (OS) was defined as the time from first administration of BI 894999 until death from any cause in patients with NUT carcinoma. For patients with 'event' as an outcome for OS: \- OS \[days\] = date of outcome - date of first treatment administration + 1. For patients with 'censored' as an outcome for OS: \- OS (censored) \[days\] = date of outcome - date of first treatment administration + 1. The Kaplan-Meier method was used to calculate the estimates.
Outcome measures
| Measure |
Phase Ia - Schedule A: 0.2 mg BI 894999
n=1 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 0.2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 0.5 mg BI 894999
n=22 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 0.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 1 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 1 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 1.5 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 2 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 5 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule B: 1.5 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2.5 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2.5 mg of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule C: 5/2.5 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 5 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: 6/3 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: 7/3.5 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 7 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 3.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule B: 1.5 mg BI 894999 (DLBCL Patients)
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
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Phase Ia - Schedule B: 2 mg BI 894999 (DLBCL Patients)
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
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Phase Ia - Schedule B: 2.5 mg BI 894999 (DLBCL Patients)
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 2.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
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Phase Ia - Schedule C: 4/2 mg BI 894999 (DLBCL Patients)
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 4 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
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Phase Ia - Schedule C: BI 894999 5/2.5 mg (DLBCL Patients)
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 5 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2.5 mg of BI 894999, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
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Phase Ib - Schedule C: BI 894999 7/3.5 mg (NC Patients)
Adult patients diagnosed with NUT carcinoma (NC) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 7 milligram (mg) of BI 894999, followed by six days intake of the maintenance dose of 3.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
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Phase Ib - Schedule B: BI 894999 2 mg (Solid Tumours Including NC)
Adult patients diagnosed with one of the following cancer types small cell lung cancer (SCLC); metastatic castrate resistant prostate cancer (mCRPC); NUT carcinoma (NC) were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
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Phase Ib - Schedule B: 2.5 mg BI 894999 (NC Patients)
Adult patients diagnosed with NUT carcinoma (NC) were administered orally 2.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days. The 2.5 mg dose could be reduced to 2 mg in case of adverse events.
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Phase Ib - Schedule B: BI 894999 2.5 mg (Solid Tumours Including NC)
Adult patients diagnosed with one of the following cancer types small cell lung cancer (SCLC); metastatic castrate resistant prostate cancer (mCRPC); colorectal cancer (CRC); NUT carcinoma (NC) were administered orally 2.5 milligram (mg) of BI 894999, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ib - Schedule C: BI 894999 6/3 mg (NC Patients)
Adult patients diagnosed with NUT carcinoma (NC) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C).
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Phase Ib - Schedule C: BI 894999 6/3 mg (NC Patients)
Adult patients diagnosed with NUT carcinoma (NC) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C).
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Phase Ib: Overall Survival
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6.6 Weeks
95% Confidence Interval could not be calculated due to insufficient number of participants with events.
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15.4 Weeks
Interval 7.6 to 32.3
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SECONDARY outcome
Timeframe: Up to 93 days.Population: mCRPC Schedule B in Phase Ib dose expansion (mCRPC): Included all mCRPC patients in the treated set who were treated in Phase Ib with Schedule B. For "Phase Ib - Schedule B: 2 or 2.5 mg BI 894999 (mCRPC patients)", DMC decided on 28Nov2018 to lower the dose of mCRPC due to safety concern, thus patients treated prior the decision received 2.5mg BI 894999 and patients treated after the decision received 2mg.
PSA response was defined as a decline in PSA value ≥50% from baseline (which is confirmed by a second value 3 to 4 weeks apart).
Outcome measures
| Measure |
Phase Ia - Schedule A: 0.2 mg BI 894999
n=11 Participants
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 0.2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 0.5 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 0.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 1 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 1 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 1.5 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 2 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 5 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule B: 1.5 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2.5 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2.5 mg of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule C: 5/2.5 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 5 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: 6/3 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: 7/3.5 mg BI 894999
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 7 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 3.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule B: 1.5 mg BI 894999 (DLBCL Patients)
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2 mg BI 894999 (DLBCL Patients)
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2.5 mg BI 894999 (DLBCL Patients)
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 2.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule C: 4/2 mg BI 894999 (DLBCL Patients)
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 4 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
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Phase Ia - Schedule C: BI 894999 5/2.5 mg (DLBCL Patients)
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 5 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2.5 mg of BI 894999, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
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Phase Ib - Schedule C: BI 894999 7/3.5 mg (NC Patients)
Adult patients diagnosed with NUT carcinoma (NC) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 7 milligram (mg) of BI 894999, followed by six days intake of the maintenance dose of 3.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ib - Schedule B: BI 894999 2 mg (Solid Tumours Including NC)
Adult patients diagnosed with one of the following cancer types small cell lung cancer (SCLC); metastatic castrate resistant prostate cancer (mCRPC); NUT carcinoma (NC) were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ib - Schedule B: 2.5 mg BI 894999 (NC Patients)
Adult patients diagnosed with NUT carcinoma (NC) were administered orally 2.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days. The 2.5 mg dose could be reduced to 2 mg in case of adverse events.
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Phase Ib - Schedule B: BI 894999 2.5 mg (Solid Tumours Including NC)
Adult patients diagnosed with one of the following cancer types small cell lung cancer (SCLC); metastatic castrate resistant prostate cancer (mCRPC); colorectal cancer (CRC); NUT carcinoma (NC) were administered orally 2.5 milligram (mg) of BI 894999, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ib - Schedule C: BI 894999 6/3 mg (NC Patients)
Adult patients diagnosed with NUT carcinoma (NC) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C).
|
Phase Ib - Schedule C: BI 894999 6/3 mg (NC Patients)
Adult patients diagnosed with NUT carcinoma (NC) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C).
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Phase Ib: Prostate Specific Antigen (PSA) Response in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
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0 Participants
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Adverse Events
Phase Ia - Schedule A: 0.2 mg BI 894999
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Phase Ia - Schedule A: 0.5 mg BI 894999
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Phase Ia - Schedule A: 1 mg BI 894999
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase Ia - Schedule A: 1.5 mg BI 894999
Serious events: 3 serious events
Other events: 6 other events
Deaths: 1 deaths
Phase Ia - Schedule A: 2 mg BI 894999
Serious events: 2 serious events
Other events: 6 other events
Deaths: 1 deaths
Phase Ia - Schedule A: 5 mg BI 894999
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Phase Ia - Schedule B: 1.5 mg BI 894999
Serious events: 3 serious events
Other events: 6 other events
Deaths: 1 deaths
Phase Ia - Schedule B: 2 mg BI 894999
Serious events: 3 serious events
Other events: 6 other events
Deaths: 1 deaths
Phase Ia - Schedule B: 2.5 mg BI 894999
Serious events: 6 serious events
Other events: 12 other events
Deaths: 2 deaths
Phase Ia - Schedule C: 5/2.5 mg BI 894999
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase Ia - Schedule C: 6/3 mg BI 894999
Serious events: 8 serious events
Other events: 15 other events
Deaths: 2 deaths
Phase Ia - Schedule C: 7/3.5 mg BI 894999
Serious events: 8 serious events
Other events: 12 other events
Deaths: 1 deaths
Phase Ia - Schedule B: 1.5 mg BI 894999 (DLBCL Patients)
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Phase Ia - Schedule B: 2 mg BI 894999 (DLBCL Patients)
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase Ia - Schedule B: 2.5 mg BI 894999 (DLBCL Patients)
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Phase Ia - Schedule C: 4/2 mg BI 894999 (DLBCL Patients
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Phase Ia - Schedule C: BI 894999 5/2.5 mg (DLBCL Patients)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Phase Ib - Schedule B: 2.5 mg BI 894999 (SCLC Patients)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase Ib - Schedule B: 2 mg BI 894999 (SCLC Patients)
Serious events: 3 serious events
Other events: 9 other events
Deaths: 1 deaths
Phase Ib - Schedule B: 2.5 mg BI 894999 (CRC Patients)
Serious events: 8 serious events
Other events: 14 other events
Deaths: 0 deaths
Phase Ib - Schedule B: 2.5 mg BI 894999 (mCRPC Patients)
Serious events: 8 serious events
Other events: 10 other events
Deaths: 0 deaths
Phase Ib - Schedule B: 2 mg BI 894999 (mCRPC Patients)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase Ib - Schedule B: 2.5 mg BI 894999 (NC Patients)
Serious events: 15 serious events
Other events: 20 other events
Deaths: 5 deaths
Phase Ib - Schedule C: BI 894999 6/3 mg (NC Patients)
Serious events: 12 serious events
Other events: 21 other events
Deaths: 2 deaths
Phase Ib - Schedule C: BI 894999 7/3.5 mg (NC Patients)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase Ia - Schedule A: 0.2 mg BI 894999
n=2 participants at risk
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 0.2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
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Phase Ia - Schedule A: 0.5 mg BI 894999
n=2 participants at risk
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 0.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
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Phase Ia - Schedule A: 1 mg BI 894999
n=3 participants at risk
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 1 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
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Phase Ia - Schedule A: 1.5 mg BI 894999
n=6 participants at risk
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
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Phase Ia - Schedule A: 2 mg BI 894999
n=6 participants at risk
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
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Phase Ia - Schedule A: 5 mg BI 894999
n=2 participants at risk
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
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Phase Ia - Schedule B: 1.5 mg BI 894999
n=6 participants at risk
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2 mg BI 894999
n=6 participants at risk
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
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Phase Ia - Schedule B: 2.5 mg BI 894999
n=13 participants at risk
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2.5 mg of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
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Phase Ia - Schedule C: 5/2.5 mg BI 894999
n=4 participants at risk
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 5 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
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Phase Ia - Schedule C: 6/3 mg BI 894999
n=15 participants at risk
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
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Phase Ia - Schedule C: 7/3.5 mg BI 894999
n=12 participants at risk
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 7 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 3.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
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Phase Ia - Schedule B: 1.5 mg BI 894999 (DLBCL Patients)
n=8 participants at risk
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
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Phase Ia - Schedule B: 2 mg BI 894999 (DLBCL Patients)
n=4 participants at risk
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
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Phase Ia - Schedule B: 2.5 mg BI 894999 (DLBCL Patients)
n=2 participants at risk
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 2.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
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Phase Ia - Schedule C: 4/2 mg BI 894999 (DLBCL Patients
n=2 participants at risk
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 4 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: BI 894999 5/2.5 mg (DLBCL Patients)
n=2 participants at risk
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 5 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2.5 mg of BI 894999, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ib - Schedule B: 2.5 mg BI 894999 (SCLC Patients)
n=3 participants at risk
Adult patients diagnosed with small cell lung cancer (SCLC) were administered 2.5 milligram (mg) of BI 894999 once daily. BI 894999 administration was performed in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water according to Schedule B (continuous intake for 14 days followed by one week off treatment in cycles of 21 days).
|
Phase Ib - Schedule B: 2 mg BI 894999 (SCLC Patients)
n=9 participants at risk
Adult patients diagnosed with small cell lung cancer (SCLC) were administered orally 2 milligram (mg) of BI 894999 once daily. BI 894999 administration was performed in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water according to Schedule B (continuous intake for 14 days followed by one week off treatment in cycles of 21 days).
|
Phase Ib - Schedule B: 2.5 mg BI 894999 (CRC Patients)
n=14 participants at risk
Adult patients diagnosed with colorectal cancer (CRC) were administered orally 2.5 milligram (mg) of BI 894999. BI 894999 administration was performed in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water according to Schedule B (continuous intake for 14 days followed by one week off treatment in cycles of 21 days).
|
Phase Ib - Schedule B: 2.5 mg BI 894999 (mCRPC Patients)
n=10 participants at risk
Adult patients diagnosed with metastatic castrate resistant prostate cancer (mCRPC) were administered orally 2.5 milligram (mg) of BI 894999 once daily. BI 894999 administration was performed in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water according to Schedule B (continuous intake for 14 days followed by one week off treatment in cycles of 21 days).
|
Phase Ib - Schedule B: 2 mg BI 894999 (mCRPC Patients)
n=1 participants at risk
Adult patients diagnosed with metastatic castrate resistant prostate cancer (mCRPC) were administered orally 2 milligram (mg) of BI 894999 once daily. BI 894999 administration was performed in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water according to Schedule B (continuous intake for 14 days followed by one week off treatment in cycles of 21 days).
|
Phase Ib - Schedule B: 2.5 mg BI 894999 (NC Patients)
n=20 participants at risk
Adult patients diagnosed with NUT carcinoma (NC) were administered orally 2.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days. The 2.5 mg dose could be reduced to 2 mg in case of adverse events.
|
Phase Ib - Schedule C: BI 894999 6/3 mg (NC Patients)
n=21 participants at risk
Adult patients diagnosed with NUT carcinoma (NC) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C).
|
Phase Ib - Schedule C: BI 894999 7/3.5 mg (NC Patients)
n=1 participants at risk
Adult patients diagnosed with NUT carcinoma (NC) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 7 milligram (mg) of BI 894999, followed by six days intake of the maintenance dose of 3.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
2/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
12.5%
1/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
1/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
66.7%
2/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
2/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
1/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Eye disorders
Uveitis
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
1/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
21.4%
3/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
2/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
General disorders
Asthenia
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
General disorders
Chest pain
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
General disorders
Death
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
General disorders
Disease progression
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
General disorders
Fatigue
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
100.0%
1/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
General disorders
General physical health deterioration
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
General disorders
Pain
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
12.5%
1/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
COVID-19
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Cystitis
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
1/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Dacryocystitis
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Device related infection
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Hepatic infection
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Infection
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Influenza
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Localised infection
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Meningitis pneumococcal
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
12.5%
1/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
11.1%
1/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
5/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Sepsis
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Spinal cord infection
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Investigations
Blood creatine phosphokinase MB increased
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
12.5%
1/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Investigations
Electrocardiogram ST segment elevation
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
1/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Investigations
Platelet count decreased
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
100.0%
1/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
2/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
100.0%
1/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Investigations
Troponin I increased
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Investigations
Troponin T increased
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
13.3%
2/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
15.0%
3/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
11.1%
1/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
12.5%
1/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
15.0%
3/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spinal cord
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Nervous system disorders
Seizure
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
2/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Renal and urinary disorders
Bladder dilatation
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
11.1%
1/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
9.5%
2/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Increased bronchial secretion
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
1/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal obstruction
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
14.3%
3/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
1/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fistula
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
100.0%
1/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Surgical and medical procedures
Euthanasia
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Vascular disorders
Embolism
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Vascular disorders
Jugular vein distension
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Vascular disorders
Vascular occlusion
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
Other adverse events
| Measure |
Phase Ia - Schedule A: 0.2 mg BI 894999
n=2 participants at risk
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 0.2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 0.5 mg BI 894999
n=2 participants at risk
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 0.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 1 mg BI 894999
n=3 participants at risk
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 1 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 1.5 mg BI 894999
n=6 participants at risk
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 2 mg BI 894999
n=6 participants at risk
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule A: 5 mg BI 894999
n=2 participants at risk
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule A was a continuous daily intake in cycles of 21 days.
|
Phase Ia - Schedule B: 1.5 mg BI 894999
n=6 participants at risk
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2 mg BI 894999
n=6 participants at risk
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2.5 mg BI 894999
n=13 participants at risk
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally 2.5 mg of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule C: 5/2.5 mg BI 894999
n=4 participants at risk
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 5 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: 6/3 mg BI 894999
n=15 participants at risk
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: 7/3.5 mg BI 894999
n=12 participants at risk
Adult patients with a confirmed diagnosis of advanced, unresectable and/or metastatic malignant solid tumours who had failed conventional treatment or for whom no therapy of proven efficacy existed or who were not amenable to standard therapies were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 7 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 3.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule B: 1.5 mg BI 894999 (DLBCL Patients)
n=8 participants at risk
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 1.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2 mg BI 894999 (DLBCL Patients)
n=4 participants at risk
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 2 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule B: 2.5 mg BI 894999 (DLBCL Patients)
n=2 participants at risk
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally 2.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days.
|
Phase Ia - Schedule C: 4/2 mg BI 894999 (DLBCL Patients
n=2 participants at risk
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 4 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ia - Schedule C: BI 894999 5/2.5 mg (DLBCL Patients)
n=2 participants at risk
Adult patients with histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 5 milligram (mg) of BI 894999, followed by six days daily intake of the maintenance dose of 2.5 mg of BI 894999, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
Phase Ib - Schedule B: 2.5 mg BI 894999 (SCLC Patients)
n=3 participants at risk
Adult patients diagnosed with small cell lung cancer (SCLC) were administered 2.5 milligram (mg) of BI 894999 once daily. BI 894999 administration was performed in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water according to Schedule B (continuous intake for 14 days followed by one week off treatment in cycles of 21 days).
|
Phase Ib - Schedule B: 2 mg BI 894999 (SCLC Patients)
n=9 participants at risk
Adult patients diagnosed with small cell lung cancer (SCLC) were administered orally 2 milligram (mg) of BI 894999 once daily. BI 894999 administration was performed in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water according to Schedule B (continuous intake for 14 days followed by one week off treatment in cycles of 21 days).
|
Phase Ib - Schedule B: 2.5 mg BI 894999 (CRC Patients)
n=14 participants at risk
Adult patients diagnosed with colorectal cancer (CRC) were administered orally 2.5 milligram (mg) of BI 894999. BI 894999 administration was performed in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water according to Schedule B (continuous intake for 14 days followed by one week off treatment in cycles of 21 days).
|
Phase Ib - Schedule B: 2.5 mg BI 894999 (mCRPC Patients)
n=10 participants at risk
Adult patients diagnosed with metastatic castrate resistant prostate cancer (mCRPC) were administered orally 2.5 milligram (mg) of BI 894999 once daily. BI 894999 administration was performed in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water according to Schedule B (continuous intake for 14 days followed by one week off treatment in cycles of 21 days).
|
Phase Ib - Schedule B: 2 mg BI 894999 (mCRPC Patients)
n=1 participants at risk
Adult patients diagnosed with metastatic castrate resistant prostate cancer (mCRPC) were administered orally 2 milligram (mg) of BI 894999 once daily. BI 894999 administration was performed in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water according to Schedule B (continuous intake for 14 days followed by one week off treatment in cycles of 21 days).
|
Phase Ib - Schedule B: 2.5 mg BI 894999 (NC Patients)
n=20 participants at risk
Adult patients diagnosed with NUT carcinoma (NC) were administered orally 2.5 milligram (mg) of BI 894999 once daily, in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water. Schedule B was a continuous intake for 14 days followed by one week off treatment in cycles of 21 days. The 2.5 mg dose could be reduced to 2 mg in case of adverse events.
|
Phase Ib - Schedule C: BI 894999 6/3 mg (NC Patients)
n=21 participants at risk
Adult patients diagnosed with NUT carcinoma (NC) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 6 milligram (mg) of BI 894999, followed by six days intake of the maintenance dose of 3 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C).
|
Phase Ib - Schedule C: BI 894999 7/3.5 mg (NC Patients)
n=1 participants at risk
Adult patients diagnosed with NUT carcinoma (NC) were administered orally once daily on Day 1 and on Day 15 of each cycle a loading dose of 7 milligram (mg) of BI 894999, followed by six days intake of the maintenance dose of 3.5 mg of BI 894999 once daily, followed by one week off, repeated every two weeks in cycles of 28 days (Schedule C). The loading and the maintenance dose were administered in the morning, after an overnight fast, 1 hour before breakfast with at least 250 milliliter (mL) of water.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Agitation
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
20.0%
4/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
20.0%
2/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Psychiatric disorders
Depression
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
1/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
13.3%
2/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
2/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Psychiatric disorders
Personality change
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
2/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
2/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
30.8%
4/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
5/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
6/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
12.5%
1/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
1/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
21.4%
3/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
90.0%
9/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
100.0%
1/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
55.0%
11/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
28.6%
6/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
9.5%
2/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
12.5%
1/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Blood and lymphatic system disorders
Lymph node haemorrhage
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
12.5%
1/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
12.5%
1/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
12.5%
1/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
2/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
23.1%
3/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
37.5%
3/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
2/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
100.0%
2/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
11.1%
1/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
2/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
1/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
2/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
83.3%
5/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
3/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
46.2%
6/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
2/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
53.3%
8/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
58.3%
7/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
4/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
100.0%
4/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
100.0%
2/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
66.7%
2/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
22.2%
2/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
35.7%
5/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
5/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
5/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
23.8%
5/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
100.0%
1/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
11.1%
1/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
2/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
9.5%
2/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
11.1%
1/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Ear and labyrinth disorders
Ear haemorrhage
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
14.3%
3/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Eye disorders
Dry eye
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Eye disorders
Vision blurred
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
100.0%
1/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
12.5%
1/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
1/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
11.1%
1/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
21.4%
3/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
19.0%
4/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
100.0%
1/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
1/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
11.1%
1/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Anal inflammation
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Angular cheilitis
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
1/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
15.4%
2/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
1/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
4/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
2/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
21.4%
3/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
30.0%
3/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
5/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
19.0%
4/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
100.0%
2/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
3/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
2/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
46.2%
6/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
75.0%
3/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
53.3%
8/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
3/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
2/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
75.0%
3/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
100.0%
2/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
100.0%
2/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
100.0%
2/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
3/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
57.1%
8/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
60.0%
6/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
20.0%
4/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
42.9%
9/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
23.1%
3/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
4/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
1/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
11.1%
1/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
2/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
100.0%
1/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
14.3%
3/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
11.1%
1/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
1/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
1/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
2/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
66.7%
4/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
2/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
15.4%
2/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
1/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
26.7%
4/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
6/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
12.5%
1/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
2/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
1/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
11.1%
1/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
42.9%
6/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
5/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
20.0%
4/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
19.0%
4/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
1/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Oral mucosal erythema
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
2/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
100.0%
2/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
1/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
1/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
100.0%
1/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
9.5%
2/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Toothache
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
1/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
3/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
2/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
1/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
20.0%
3/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
4/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
12.5%
1/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
1/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
1/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
22.2%
2/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
21.4%
3/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
60.0%
6/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
14.3%
3/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
General disorders
Asthenia
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
2/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
11.1%
1/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
14.3%
2/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
9.5%
2/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
General disorders
Chest discomfort
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
General disorders
Chest pain
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
1/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
12.5%
1/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
General disorders
Chills
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
1/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
General disorders
Facial pain
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
General disorders
Fatigue
|
100.0%
2/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
100.0%
3/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
66.7%
4/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
66.7%
4/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
100.0%
2/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
3/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
46.2%
6/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
2/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
53.3%
8/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
83.3%
10/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
75.0%
3/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
1/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
3/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
42.9%
6/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
60.0%
6/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
40.0%
8/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
47.6%
10/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
General disorders
Gait disturbance
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
General disorders
General physical health deterioration
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
General disorders
Generalised oedema
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
General disorders
Hypothermia
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
General disorders
Malaise
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
General disorders
Oedema peripheral
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
23.1%
3/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
1/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
11.1%
1/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
30.0%
3/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
General disorders
Pain
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
2/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
General disorders
Peripheral swelling
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
General disorders
Pyrexia
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
15.4%
2/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
1/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
12.5%
1/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
20.0%
4/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
23.8%
5/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
1/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
11.1%
1/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Immune system disorders
Iodine allergy
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
15.4%
2/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
12.5%
1/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
11.1%
1/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
12.5%
1/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
14.3%
2/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
30.0%
3/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
100.0%
1/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
1/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Cystitis
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
1/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
1/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
11.1%
1/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Genital herpes simplex
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Genital infection fungal
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
11.1%
1/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Herpes dermatitis
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
1/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
20.0%
2/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
12.5%
1/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
14.3%
2/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Impetigo
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Infection
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Influenza
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
12.5%
1/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Oesophageal infection
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
2/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
9.5%
2/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Respiratory tract infection bacterial
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
1/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
1/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Injury, poisoning and procedural complications
Tongue injury
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Injury, poisoning and procedural complications
Urinary tract stoma complication
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
100.0%
1/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Investigations
Activated partial thromboplastin time shortened
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
1/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
22.2%
2/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
30.0%
6/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
19.0%
4/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
13.3%
2/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
1/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
11.1%
1/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
100.0%
1/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
5/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
100.0%
1/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
1/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
2/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Investigations
Blood antidiuretic hormone decreased
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
11.1%
1/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
2/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
14.3%
2/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
2/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
100.0%
1/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
1/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
11.1%
1/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
5/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
2/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Investigations
Blood glucose increased
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
11.1%
1/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
11.1%
1/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Investigations
Cardiac murmur
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
12.5%
1/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Investigations
Cortisol increased
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Investigations
Echocardiogram abnormal
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
13.3%
2/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Investigations
Electrocardiogram PR prolongation
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
11.1%
1/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Investigations
Electrocardiogram ST segment elevation
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
11.1%
1/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
2/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
5/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
100.0%
1/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
3/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Investigations
Platelet count decreased
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
2/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
11.1%
1/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
20.0%
2/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
100.0%
1/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
40.0%
8/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
38.1%
8/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Investigations
Prothrombin level decreased
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Investigations
Troponin I increased
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
2/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Investigations
Troponin T increased
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
2/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
15.4%
2/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
2/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
2/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
1/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
1/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
5/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Investigations
Troponin increased
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
2/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Investigations
Urine output decreased
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Investigations
Weight decreased
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
2/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
2/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
12.5%
1/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
11.1%
1/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
40.0%
4/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
14.3%
3/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
20.0%
4/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
9.5%
2/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
11.1%
1/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Metabolism and nutrition disorders
Cell death
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
1/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
3/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
2/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
100.0%
2/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
30.8%
4/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
1/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
26.7%
4/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
6/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
12.5%
1/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
2/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
100.0%
2/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
1/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
22.2%
2/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
7/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
60.0%
6/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
100.0%
1/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
5/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
14.3%
3/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
12.5%
1/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Metabolism and nutrition disorders
Folate deficiency
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
11.1%
1/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
2/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
19.0%
4/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
1/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
13.3%
2/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
20.0%
4/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
2/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
20.0%
4/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
2/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
20.0%
3/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
14.3%
2/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
15.0%
3/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
19.0%
4/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
13.3%
2/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
20.0%
4/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
1/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
11.1%
1/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
40.0%
8/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
23.8%
5/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
100.0%
2/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
2/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
3/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
1/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
20.0%
2/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
15.0%
3/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
11.1%
1/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
2/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
19.0%
4/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
1/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
15.4%
2/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
15.0%
3/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
14.3%
3/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
12.5%
1/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
11.1%
1/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
14.3%
2/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
15.4%
2/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
1/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
15.4%
2/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
2/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pubic pain
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
2/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
9.5%
2/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
11.1%
1/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Nervous system disorders
Agnosia
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Nervous system disorders
Cauda equina syndrome
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
15.0%
3/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Nervous system disorders
Dysgeusia
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
2/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
2/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
23.1%
3/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
2/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
3/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
12.5%
1/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
3/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
21.4%
3/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
40.0%
4/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
20.0%
4/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
14.3%
3/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
1/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
23.1%
3/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
1/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
2/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
12.5%
1/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
15.0%
3/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
9.5%
2/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Nervous system disorders
Motor dysfunction
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
12.5%
1/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
2/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
2/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Reproductive system and breast disorders
Oedema genital
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Reproductive system and breast disorders
Perineal pain
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
2/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
100.0%
2/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
23.1%
3/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
1/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
20.0%
3/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
12.5%
1/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
66.7%
2/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
3/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
21.4%
3/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
2/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
23.8%
5/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
11.1%
1/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
1/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
38.5%
5/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
1/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
3/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
12.5%
1/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
66.7%
2/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
44.4%
4/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
21.4%
3/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
40.0%
4/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
15.0%
3/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
1/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
2/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
2/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
20.0%
2/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
100.0%
1/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
2/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
19.0%
4/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
11.1%
1/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
1/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
13.3%
2/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
15.4%
2/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
12.5%
1/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
12.5%
1/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
1/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
100.0%
1/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
12.5%
1/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
15.4%
2/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
1/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
2/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
2/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis psoriasiform
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
12.5%
1/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
100.0%
2/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
9.5%
2/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Macule
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
12.5%
1/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
2/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
1/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
9.5%
2/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
100.0%
1/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
5.0%
1/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
23.1%
3/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
12.5%
1/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
4.8%
1/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
33.3%
1/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
11.1%
1/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
2/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
14.3%
3/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Vascular disorders
Haematoma
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
1/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
100.0%
2/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
14.3%
2/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
100.0%
1/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Vascular disorders
Hypertension
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
16.7%
1/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
15.4%
2/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
2/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
25.0%
3/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
10.0%
1/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
19.0%
4/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
50.0%
1/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.1%
1/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
6.7%
1/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
8.3%
1/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Vascular disorders
Pallor
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
7.7%
1/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
100.0%
1/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
|
Infections and infestations
Stoma site infection
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/6 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/13 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/15 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/12 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/8 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/4 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/2 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/3 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/9 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/14 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/10 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/20 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
0.00%
0/21 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
100.0%
1/1 • [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib.
Treated Set (TS): Included all patients who were dispensed study treatment and were documented to have taken at least one dose of the study treatment.
|
Additional Information
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Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER