Trial Outcomes & Findings for A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors (NCT NCT03899792)
NCT ID: NCT03899792
Last Updated: 2026-01-06
Results Overview
A DLT was any of the adverse events that starts on or after the first administration of study drug listed below, as defined by the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. * Any Grade(G) ≥3 nonhematologic toxicity except G3 fatigue, nausea, tendon reflex decrease, weight gain attributable to normal growth and development. * G3 vomiting/diarrhea was DLT only if it persists \>48 h despite standard of care treatment. * G4 vomiting/diarrhea was DLT regardless of duration. * Any toxicity, regardless of the NCI CTCAE v5.0 grade, resulting in discontinuation or dose reduction of treatment (except symptoms related to progressive disease (PD)). * G4/G3 thrombocytopenia with G1 or higher bleeding. * G4 anemia lasting \>8 days, despite supportive therapy. * G4 neutropenia, lasting \>8 days, despite supportive therapy
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1/PHASE2
Target enrollment
36 participants
Primary outcome timeframe
Cycle 1 (28 Day Cycle)
Results posted on
2026-01-06
Participant Flow
The study consisted of two parts: Phase 1 (dose-escalation) and Phase 2 (dose-expansion). In Phase 1, three participants received selpercatinib, with dosing based on body surface area. The starting dose level was 92 mg/m\^2 (maximum 160 mg, twice daily (BID\]), selected to approximate the exposure associated with the recommended Phase 2 dose (RP2D) in adults. The Phase 2 portion opened for enrollment after confirmation of the RP2D of 92 mg/m\^2 (maximum 160 mg BID).
In Phase 2, participants were assigned to one of three disease-based groups: medullary thyroid cancer (MTC), papillary thyroid cancer (PTC), or Other Solid Tumors and received selpercatinib at the RP2D. Current primary results are reported, and additional results will be reported during study completion.
Participant milestones
| Measure |
Dose Escalation Cohort (Phase 1)
Participants received selpercatinib given orally BID, with the dose based on body surface area in a 28-day cycle. The starting dose level of 92mg/m\^2 BID (maximum160 mg BID) was intended to deliver equivalent exposure to the RP2D in adults.
|
Cohort 1 (Phase 2): Medullary Thyroid Cancer (MTC) Group
Participants in this cohort had MTC and received 92mg/m\^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle.
The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation.
|
Cohort 2 (Phase 2): Papillary Thyroid Cancer (PTC) Group
Participants in this cohort had PTC and received 92mg/m\^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle.
The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation.
|
Cohort 3 (Phase 2): Other Cancer Group
Participants in this cohort had other (RET-altered non-thyroid) cancer and received 92mg/m\^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle.
The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation.
|
|---|---|---|---|---|
|
Phase 1
STARTED
|
3
|
0
|
0
|
0
|
|
Phase 1
COMPLETED
|
3
|
0
|
0
|
0
|
|
Phase 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Phase 2
STARTED
|
0
|
15
|
15
|
6
|
|
Phase 2
Received At Least 1 Dose of Study Drug
|
0
|
15
|
15
|
6
|
|
Phase 2
COMPLETED
|
0
|
0
|
0
|
0
|
|
Phase 2
NOT COMPLETED
|
0
|
15
|
15
|
6
|
Reasons for withdrawal
| Measure |
Dose Escalation Cohort (Phase 1)
Participants received selpercatinib given orally BID, with the dose based on body surface area in a 28-day cycle. The starting dose level of 92mg/m\^2 BID (maximum160 mg BID) was intended to deliver equivalent exposure to the RP2D in adults.
|
Cohort 1 (Phase 2): Medullary Thyroid Cancer (MTC) Group
Participants in this cohort had MTC and received 92mg/m\^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle.
The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation.
|
Cohort 2 (Phase 2): Papillary Thyroid Cancer (PTC) Group
Participants in this cohort had PTC and received 92mg/m\^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle.
The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation.
|
Cohort 3 (Phase 2): Other Cancer Group
Participants in this cohort had other (RET-altered non-thyroid) cancer and received 92mg/m\^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle.
The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation.
|
|---|---|---|---|---|
|
Phase 2
Ongoing Treatment
|
0
|
13
|
14
|
2
|
|
Phase 2
Death
|
0
|
0
|
0
|
4
|
|
Phase 2
Lost to Follow-up
|
0
|
1
|
1
|
0
|
|
Phase 2
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
Baseline Characteristics
The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
Baseline characteristics by cohort
| Measure |
Dose Escalation Cohort (Phase 1)
n=3 Participants
Participants received selpercatinib given orally BID, with the dose based on body surface area in a 28-day cycle. The starting dose level of 92mg/m\^2 (maximum160 mg BID) was intended to deliver equivalent exposure to the RP2D in adults.
|
Cohort 1 (Phase 2): MTC Group
n=13 Participants
Participants in this cohort had MTC and received 92mg/m\^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle.
The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation.
|
Cohort 2 (Phase 2): PTC Group
n=15 Participants
Participants in this cohort had PTC and received 92mg/m\^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle.
The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation.
|
Cohort 3 (Phase 2): Other Cancer Group
n=5 Participants
Participants in this cohort had other (RET-altered non-thyroid) cancer and received 92mg/m\^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle.
The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
Age · <=18 years
|
2 Participants
n=37 Participants
|
10 Participants
n=56 Participants
|
13 Participants
n=82 Participants
|
5 Participants
n=31 Participants
|
30 Participants
n=5 Participants
|
|
Age, Customized
Age · Between 18 and 65 years
|
1 Participants
n=37 Participants
|
3 Participants
n=56 Participants
|
2 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=37 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
5 Participants
n=56 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
7 Participants
n=82 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
3 Participants
n=31 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
17 Participants
n=5 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
|
Sex: Female, Male
Male
|
1 Participants
n=37 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
8 Participants
n=56 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
8 Participants
n=82 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
2 Participants
n=31 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
19 Participants
n=5 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
|
Region of Enrollment
Germany
|
0 Participants
n=37 Participants
|
2 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=37 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
0 Participants
n=56 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
4 Participants
n=82 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
0 Participants
n=31 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
7 Participants
n=5 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=37 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
11 Participants
n=56 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
11 Participants
n=82 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
4 Participants
n=31 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
26 Participants
n=5 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
2 Participants
n=56 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
0 Participants
n=82 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
1 Participants
n=31 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
3 Participants
n=5 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
0 Participants
n=56 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
0 Participants
n=82 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
0 Participants
n=31 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
0 Participants
n=5 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=37 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
0 Participants
n=56 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
7 Participants
n=82 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
3 Participants
n=31 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
10 Participants
n=5 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
0 Participants
n=56 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
0 Participants
n=82 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
0 Participants
n=31 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
0 Participants
n=5 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=37 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
2 Participants
n=56 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
0 Participants
n=82 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
0 Participants
n=31 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
2 Participants
n=5 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
|
Race (NIH/OMB)
White
|
3 Participants
n=37 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
9 Participants
n=56 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
6 Participants
n=82 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
0 Participants
n=31 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
18 Participants
n=5 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=37 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
0 Participants
n=56 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
0 Participants
n=82 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
0 Participants
n=31 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
0 Participants
n=5 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
2 Participants
n=56 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
2 Participants
n=82 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
2 Participants
n=31 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
6 Participants
n=5 Participants • The Baseline data were planned to be presented according to Phases. Here "number analyzed" signifies participants who were evaluable for specified Phase of the study.
|
|
Region of Enrollment
Canada
|
0 Participants
n=37 Participants
|
2 Participants
n=56 Participants
|
2 Participants
n=82 Participants
|
1 Participants
n=31 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
4 Participants
n=82 Participants
|
2 Participants
n=31 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=37 Participants
|
3 Participants
n=56 Participants
|
4 Participants
n=82 Participants
|
1 Participants
n=31 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
2 Participants
n=82 Participants
|
1 Participants
n=31 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
0 Participants
n=37 Participants
|
1 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
2 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
0 Participants
n=37 Participants
|
1 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
0 Participants
n=37 Participants
|
4 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
1 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (28 Day Cycle)Population: All participants in Phase 1 of the study who received at least one dose of the study drug.
A DLT was any of the adverse events that starts on or after the first administration of study drug listed below, as defined by the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. * Any Grade(G) ≥3 nonhematologic toxicity except G3 fatigue, nausea, tendon reflex decrease, weight gain attributable to normal growth and development. * G3 vomiting/diarrhea was DLT only if it persists \>48 h despite standard of care treatment. * G4 vomiting/diarrhea was DLT regardless of duration. * Any toxicity, regardless of the NCI CTCAE v5.0 grade, resulting in discontinuation or dose reduction of treatment (except symptoms related to progressive disease (PD)). * G4/G3 thrombocytopenia with G1 or higher bleeding. * G4 anemia lasting \>8 days, despite supportive therapy. * G4 neutropenia, lasting \>8 days, despite supportive therapy
Outcome measures
| Measure |
Dose Escalation Cohort (Phase 1)
n=3 Participants
Participants received selpercatinib given orally BID, with the dose based on body surface area in a 28-day cycle. The starting dose level of 92mg/m\^2 (maximum160 mg BID) was intended to deliver equivalent exposure to the RP2D in adults.
|
Cohort 2 (Phase 2): PTC Group
Participants in this cohort had PTC and received 92mg/m\^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle.
The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation.
|
Cohort 3 (Phase 2): Other Cancer Group
Participants in this cohort had other (RET-altered non-thyroid) cancer and received 92mg/m\^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle.
The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation.
|
|---|---|---|---|
|
Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Date of first dose to disease progression or death (Up to 62.4 Months)Population: All participants who received at least one dose of study drug.
ORR: Percentage of participants who achieve best overall response Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST). * CR is defined as disappearance of all target lesions. * PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Outcome measures
| Measure |
Dose Escalation Cohort (Phase 1)
n=15 Participants
Participants received selpercatinib given orally BID, with the dose based on body surface area in a 28-day cycle. The starting dose level of 92mg/m\^2 (maximum160 mg BID) was intended to deliver equivalent exposure to the RP2D in adults.
|
Cohort 2 (Phase 2): PTC Group
n=15 Participants
Participants in this cohort had PTC and received 92mg/m\^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle.
The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation.
|
Cohort 3 (Phase 2): Other Cancer Group
n=6 Participants
Participants in this cohort had other (RET-altered non-thyroid) cancer and received 92mg/m\^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle.
The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation.
|
|---|---|---|---|
|
Phase 2: Percentage of Participants With Overall Response Rate (ORR) in Study
|
60.0 Percentage of participants
|
53.3 Percentage of participants
|
33.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Days 1 and 8 of Cycle 1, Day 1 of Cycle 3 and Day 8 after Intra-participant Dose Escalation (each cycle is 28 days)Outcome data will be provided after the study is completed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1 and 8 of Cycle 1, Day 1 of Cycle 3 and Day 8 after Intra-participant Dose Escalation (each cycle is 28 days)Outcome data will be provided after the study is completed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1 and 8 of Cycle 1, Day 1 of Cycle 3 and Day 8 after Intra-participant Dose Escalation (each cycle is 28 days)Outcome data will be provided after the study is completed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1 and 8 of Cycle 1, Day 1 of Cycle 3 and Day 8 after Intra-participant Dose Escalation (each cycle is 28 days)Outcome data will be provided after the study is completed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1 (28 days)Outcome data will be provided after the study is completed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Progressive Disease or Death due to any cause (Estimated up to 12 months)Outcome data will be provided after the study is completed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsOutcome data will be provided after the study is completed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsOutcome data will be provided after the study is completed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately every 8 weeks for one year, then every 12 weeks, and 7 days after the last dose (for up to 2 years) in participants who have not progressed.Outcome data will be provided after the study is completed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately every 8 weeks for one year, then every 12 weeks, and 7 days after the last dose (for up to 2 years) in participants who have not progressed.Outcome data will be provided after the study is completed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately every 8 weeks for one year, then every 12 weeks, and 7 days after the last dose (for up to 2 years) in participants who have not progressed.Outcome data will be provided after the study is completed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately every 8 weeks for one year, then every 12 weeks, and 7 days after the last dose (for up to 2 years) in participants who have not progressed.Outcome data will be provided after the study is completed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately every 8 weeks for one year, then every 12 weeks, and 7 days after the last dose (for up to 2 years) in participants who have not progressed.Outcome data will be provided after the study is completed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately every 8 weeks for one year, then every 12 weeks, and 7 days after the last dose (for up to 2 years) in participants who have not progressed.Outcome data will be provided after the study is completed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately every 8 weeks for one year, then every 12 weeks, and 7 days after the last dose (for up to 2 years) in participants who have not progressed.Outcome data will be provided after the study is completed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately every 8 weeks for one year, then every 12 weeks, 7 days after the last dose (for up to 2 years) in participants who have not progressed.Outcome data will be provided after the study is completed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately every 8 weeks for one year, then every 12 weeks, 7 days after the last dose (for up to 2 years) in participants who have not progressed.Outcome data will be provided after the study is completed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the time of informed consent, for approximately 24 months (or earlier if the participants discontinues from the study), and through Safety Follow-up (28 days after the last dose)Outcome data will be provided after the study is completed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsOutcome data will be provided after the study is completed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsTumor stage is described according to the Tumor, Node, Metastasis (TNM)Classification of malignant tumors of the Union for International Cancer Control (UICC). Outcome data will be provided after the study is completed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsTumor margins after surgery are classified into four groups using the International Cancer Control (UICC)-R classification and the Intergroup Rhabdomyosarcoma Staging (IRS) systems: 1) Complete tumor resection with histologically free margins, 2) Macroscopic resection but invaded margins on histology, 3)Macroscopic residual tumor and 4) Distant metastatic tumor. Outcome data will be provided after the study is completed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsOutcome data will be provided after the study is completed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsOutcome data will be provided after the study is completed.
Outcome measures
Outcome data not reported
Adverse Events
Cohort 1: MTC Group
Serious events: 8 serious events
Other events: 15 other events
Deaths: 0 deaths
Cohort 2: PTC Group
Serious events: 4 serious events
Other events: 15 other events
Deaths: 0 deaths
Cohort 3: Other Cancer Group
Serious events: 3 serious events
Other events: 5 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Cohort 1: MTC Group
n=15 participants at risk
Participants in this cohort had MTC and received 92mg/m\^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle.
The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation.
|
Cohort 2: PTC Group
n=15 participants at risk
Participants in this cohort had PTC and received 92mg/m\^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle.
The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation.
|
Cohort 3: Other Cancer Group
n=6 participants at risk
Participants in this cohort had other (RET-altered non-thyroid) cancer and received 92mg/m\^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle.
The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
16.7%
1/6 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Gastrointestinal disorders
Constipation
|
6.7%
1/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Gastrointestinal disorders
Gastrointestinal fistula
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
16.7%
1/6 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
2/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
16.7%
1/6 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
16.7%
1/6 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Pneumonia
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Rhinovirus infection
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Sepsis
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
16.7%
1/6 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Wound infection
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Musculoskeletal and connective tissue disorders
Epiphysiolysis
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal death
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
Other adverse events
| Measure |
Cohort 1: MTC Group
n=15 participants at risk
Participants in this cohort had MTC and received 92mg/m\^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle.
The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation.
|
Cohort 2: PTC Group
n=15 participants at risk
Participants in this cohort had PTC and received 92mg/m\^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle.
The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation.
|
Cohort 3: Other Cancer Group
n=6 participants at risk
Participants in this cohort had other (RET-altered non-thyroid) cancer and received 92mg/m\^2 (maximum160 mg BID) of selpercatinib BID orally on Days 1 through 28 of a 28-day cycle.
The treatment was continued until participants experienced a progressive disease, unacceptable toxicity, or other protocol-defined reason for discontinuation.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
26.7%
4/15 • Number of events 15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
33.3%
2/6 • Number of events 4 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
16.7%
1/6 • Number of events 4 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 3 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Cardiac disorders
Conduction disorder
|
6.7%
1/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Cardiac disorders
Sinus bradycardia
|
13.3%
2/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Cardiac disorders
Sinus tachycardia
|
13.3%
2/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
20.0%
3/15 • Number of events 4 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
16.7%
1/6 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Congenital, familial and genetic disorders
Gilbert's syndrome
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Ear and labyrinth disorders
External ear inflammation
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
16.7%
1/6 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Endocrine disorders
Adrenal insufficiency
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Eye disorders
Eye pain
|
6.7%
1/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Endocrine disorders
Hyperparathyroidism
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Endocrine disorders
Hypothyroidism
|
13.3%
2/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
13.3%
2/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Eye disorders
Blepharitis
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Eye disorders
Conjunctivitis allergic
|
6.7%
1/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Eye disorders
Dry eye
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
16.7%
1/6 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Eye disorders
Eye disorder
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Eye disorders
Eyelid ptosis
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Eye disorders
Glaucoma
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Eye disorders
Keratitis
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Eye disorders
Periorbital oedema
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
16.7%
1/6 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Eye disorders
Visual impairment
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
16.7%
1/6 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.7%
1/15 • Number of events 3 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Gastrointestinal disorders
Abdominal pain
|
26.7%
4/15 • Number of events 4 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
26.7%
4/15 • Number of events 11 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
50.0%
3/6 • Number of events 5 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 4 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Gastrointestinal disorders
Anal incontinence
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Gastrointestinal disorders
Angular cheilitis
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
20.0%
3/15 • Number of events 3 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Gastrointestinal disorders
Colitis
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
5/15 • Number of events 12 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
13.3%
2/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
16.7%
1/6 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Gastrointestinal disorders
Dental caries
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
5/15 • Number of events 13 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
66.7%
10/15 • Number of events 26 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
33.3%
2/6 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Gastrointestinal disorders
Dyspepsia
|
20.0%
3/15 • Number of events 3 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Gastrointestinal disorders
Flatulence
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Gastrointestinal disorders
Gastritis
|
20.0%
3/15 • Number of events 3 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Gastrointestinal disorders
Gastrointestinal fistula
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
16.7%
1/6 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Gastrointestinal disorders
Gastrointestinal oedema
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Gastrointestinal disorders
Gingival pain
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Gastrointestinal disorders
Glossitis
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Gastrointestinal disorders
Inguinal hernia
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Gastrointestinal disorders
Lip blister
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Gastrointestinal disorders
Nausea
|
53.3%
8/15 • Number of events 12 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
33.3%
5/15 • Number of events 15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
16.7%
1/6 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Gastrointestinal disorders
Oral disorder
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
13.3%
2/15 • Number of events 3 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
6.7%
1/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Gastrointestinal disorders
Stomatitis
|
13.3%
2/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
16.7%
1/6 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Gastrointestinal disorders
Tongue eruption
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Gastrointestinal disorders
Vomiting
|
60.0%
9/15 • Number of events 18 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
13.3%
2/15 • Number of events 8 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
General disorders
Asthenia
|
6.7%
1/15 • Number of events 3 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
13.3%
2/15 • Number of events 4 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
General disorders
Chest pain
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
General disorders
Discomfort
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
General disorders
Face oedema
|
26.7%
4/15 • Number of events 4 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 3 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
16.7%
1/6 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
General disorders
Fatigue
|
26.7%
4/15 • Number of events 8 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
26.7%
4/15 • Number of events 8 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
General disorders
Gait disturbance
|
20.0%
3/15 • Number of events 3 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
General disorders
Generalised oedema
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
General disorders
Inflammation
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
General disorders
Influenza like illness
|
13.3%
2/15 • Number of events 4 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
General disorders
Localised oedema
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
General disorders
Malaise
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
General disorders
Medical device site erosion
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
General disorders
Non-cardiac chest pain
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
13.3%
2/15 • Number of events 4 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
General disorders
Oedema peripheral
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
General disorders
Pain
|
6.7%
1/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
General disorders
Pyrexia
|
46.7%
7/15 • Number of events 13 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
26.7%
4/15 • Number of events 4 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
50.0%
3/6 • Number of events 7 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
General disorders
Swelling
|
6.7%
1/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Immune system disorders
Contrast media allergy
|
13.3%
2/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Immune system disorders
Drug hypersensitivity
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Immune system disorders
Hypersensitivity
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Aeromonas infection
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Beta haemolytic streptococcal infection
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Body tinea
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Bronchitis
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Clostridium colitis
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Conjunctivitis
|
13.3%
2/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Corona virus infection
|
40.0%
6/15 • Number of events 8 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
26.7%
4/15 • Number of events 5 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Cystitis
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Device related infection
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
16.7%
1/6 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Ear infection
|
13.3%
2/15 • Number of events 3 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Enterovirus infection
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Eye infection
|
13.3%
2/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Folliculitis
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Gastroenteritis
|
13.3%
2/15 • Number of events 3 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Gastrointestinal bacterial overgrowth
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 3 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Influenza
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Lip infection
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Moraxella infection
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Nail infection
|
13.3%
2/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Nasopharyngitis
|
20.0%
3/15 • Number of events 4 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
13.3%
2/15 • Number of events 3 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Otitis externa
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Otitis media
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Paronychia
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Pathogen resistance
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Pharyngitis streptococcal
|
6.7%
1/15 • Number of events 5 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Respiratory tract infection
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Rhinitis
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Sinusitis
|
13.3%
2/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Skin infection
|
13.3%
2/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Stoma site infection
|
13.3%
2/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Tracheitis
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Upper respiratory tract infection
|
53.3%
8/15 • Number of events 16 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
13.3%
2/15 • Number of events 5 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Urinary tract infection
|
26.7%
4/15 • Number of events 5 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
16.7%
1/6 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Vaginal infection
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Varicella zoster virus infection
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
16.7%
1/6 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Viral infection
|
13.3%
2/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Infections and infestations
Wound infection
|
6.7%
1/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Injury, poisoning and procedural complications
Fall
|
13.3%
2/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Injury, poisoning and procedural complications
Fracture
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
13.3%
2/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Injury, poisoning and procedural complications
Lip injury
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
20.0%
3/15 • Number of events 5 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
16.7%
1/6 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
6.7%
1/15 • Number of events 3 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
16.7%
1/6 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
6.7%
1/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Investigations
Alanine aminotransferase increased
|
26.7%
4/15 • Number of events 6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
33.3%
5/15 • Number of events 9 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
50.0%
3/6 • Number of events 6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
3/15 • Number of events 7 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
53.3%
8/15 • Number of events 13 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
50.0%
3/6 • Number of events 4 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Investigations
Blood urea increased
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Investigations
Blood 1,25-dihydroxycholecalciferol decreased
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Investigations
Blood alkaline phosphatase increased
|
26.7%
4/15 • Number of events 4 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
13.3%
2/15 • Number of events 4 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
33.3%
2/6 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Investigations
Blood bicarbonate decreased
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
16.7%
1/6 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Investigations
Blood bilirubin increased
|
20.0%
3/15 • Number of events 26 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
20.0%
3/15 • Number of events 45 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
33.3%
2/6 • Number of events 3 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Investigations
Blood calcitonin increased
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Investigations
Blood calcium decreased
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 3 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Investigations
Blood calcium increased
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Investigations
Blood cholesterol increased
|
6.7%
1/15 • Number of events 3 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 7 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Investigations
Blood creatinine increased
|
13.3%
2/15 • Number of events 4 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
20.0%
3/15 • Number of events 7 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Investigations
Blood folate decreased
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Investigations
Blood lactate dehydrogenase increased
|
26.7%
4/15 • Number of events 10 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
33.3%
2/6 • Number of events 3 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Investigations
Blood potassium increased
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
20.0%
3/15 • Number of events 5 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Investigations
Blood urine present
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Investigations
Electrocardiogram qrs complex prolonged
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Investigations
Electrocardiogram qt prolonged
|
13.3%
2/15 • Number of events 6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 4 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
16.7%
1/6 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Investigations
Electrocardiogram t wave abnormal
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
13.3%
2/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Investigations
Haemoglobin increased
|
6.7%
1/15 • Number of events 3 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Investigations
Lipase increased
|
6.7%
1/15 • Number of events 4 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Investigations
Lymphocyte count decreased
|
20.0%
3/15 • Number of events 5 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
16.7%
1/6 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
16.7%
1/6 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Investigations
Neutrophil count decreased
|
13.3%
2/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
13.3%
2/15 • Number of events 21 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Investigations
Platelet count decreased
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Investigations
Pregnancy test positive
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Investigations
Thyroglobulin increased
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 4 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Investigations
Urine analysis abnormal
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Investigations
Vitamin b12 decreased
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Investigations
Vitamin d decreased
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Investigations
Weight decreased
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Investigations
Weight increased
|
26.7%
4/15 • Number of events 9 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
20.0%
3/15 • Number of events 5 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Investigations
White blood cell count decreased
|
20.0%
3/15 • Number of events 7 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
13.3%
2/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
6.7%
1/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
26.7%
4/15 • Number of events 12 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
20.0%
3/15 • Number of events 3 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
20.0%
3/15 • Number of events 3 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
16.7%
1/6 • Number of events 3 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
16.7%
1/6 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
33.3%
5/15 • Number of events 15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
20.0%
3/15 • Number of events 4 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
16.7%
1/6 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
46.7%
7/15 • Number of events 28 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
26.7%
4/15 • Number of events 13 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
13.3%
2/15 • Number of events 3 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
13.3%
2/15 • Number of events 8 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.7%
1/15 • Number of events 3 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
16.7%
1/6 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
13.3%
2/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
16.7%
1/6 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Metabolism and nutrition disorders
Vitamin b12 deficiency
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
53.3%
8/15 • Number of events 12 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
13.3%
2/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
26.7%
4/15 • Number of events 4 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
33.3%
2/6 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
16.7%
1/6 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Musculoskeletal and connective tissue disorders
Knee deformity
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
16.7%
1/6 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
13.3%
2/15 • Number of events 4 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
46.7%
7/15 • Number of events 20 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
13.3%
2/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
16.7%
1/6 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
13.3%
2/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Musculoskeletal and connective tissue disorders
Sever's disease
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroma
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papilloma
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Nervous system disorders
Aphonia
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Nervous system disorders
Disturbance in attention
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Nervous system disorders
Dizziness
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
26.7%
4/15 • Number of events 4 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Nervous system disorders
Headache
|
53.3%
8/15 • Number of events 11 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
26.7%
4/15 • Number of events 8 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Nervous system disorders
Lethargy
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Nervous system disorders
Memory impairment
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Nervous system disorders
Nervous system disorder
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Nervous system disorders
Neuropathy peripheral
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Nervous system disorders
Paraesthesia
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Nervous system disorders
Sciatica
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Nervous system disorders
Seizure
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Nervous system disorders
Syncope
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Nervous system disorders
Tremor
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Psychiatric disorders
Depression
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Psychiatric disorders
Depressive symptom
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Psychiatric disorders
Insomnia
|
20.0%
3/15 • Number of events 3 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Psychiatric disorders
Irritability
|
6.7%
1/15 • Number of events 3 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Psychiatric disorders
Libido decreased
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Psychiatric disorders
Sleep disorder
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
16.7%
1/6 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
33.3%
2/6 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Renal and urinary disorders
Nitrituria
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Renal and urinary disorders
Pollakiuria
|
6.7%
1/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Renal and urinary disorders
Proteinuria
|
20.0%
3/15 • Number of events 4 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Renal and urinary disorders
Urinary incontinence
|
6.7%
1/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
13.3%
2/15 • Number of events 4 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
13.3%
2/15 • Number of events 4 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Reproductive system and breast disorders
Menorrhagia
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
13.3%
2/15 • Number of events 3 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Reproductive system and breast disorders
Ovarian rupture
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Reproductive system and breast disorders
Penile pain
|
13.3%
2/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Respiratory, thoracic and mediastinal disorders
Acquired diaphragmatic eventration
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
40.0%
6/15 • Number of events 8 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
26.7%
4/15 • Number of events 5 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
16.7%
1/6 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
6.7%
1/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
13.3%
2/15 • Number of events 3 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 3 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
40.0%
6/15 • Number of events 12 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
13.3%
2/15 • Number of events 3 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
33.3%
2/6 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Vascular disorders
Hypertension
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 10 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
16.7%
1/6 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal pain
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
13.3%
2/15 • Number of events 5 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
26.7%
4/15 • Number of events 5 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
26.7%
4/15 • Number of events 7 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
13.3%
2/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.7%
1/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
13.3%
2/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
16.7%
1/6 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Skin and subcutaneous tissue disorders
Acne
|
20.0%
3/15 • Number of events 7 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
13.3%
2/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
6.7%
1/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
13.3%
2/15 • Number of events 4 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Skin and subcutaneous tissue disorders
Hair texture abnormal
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
6.7%
1/15 • Number of events 3 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
13.3%
2/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
6.7%
1/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Skin and subcutaneous tissue disorders
Palmoplantar keratoderma
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.3%
2/15 • Number of events 4 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
16.7%
1/6 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
20.0%
3/15 • Number of events 3 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
13.3%
2/15 • Number of events 3 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
16.7%
1/6 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 2 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Surgical and medical procedures
Dental operation
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Vascular disorders
Flushing
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Vascular disorders
Hot flush
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Vascular disorders
Hypotension
|
26.7%
4/15 • Number of events 4 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
|
Vascular disorders
Raynaud's phenomenon
|
6.7%
1/15 • Number of events 1 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/15 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
0.00%
0/6 • Baseline up to 64 months
The Safety Analysis data presented for overall population irrespective of phases. All participants who received at least one dose of the study drug. Per prespecified analysis plan, all Phase 1 and Phase 2 participants were planned to be analyzed together for Adverse events and Mortality data.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60