Trial Outcomes & Findings for A Phase I/II Trial of Pomalidomide and Dexamethasone in Subjects With Previously-Treated AL Amyloidosis (NCT NCT01570387)
NCT ID: NCT01570387
Last Updated: 2020-09-22
Results Overview
Number of patients in Phase I cohort 1 experiencing dose-limiting toxicity at the 2 milligram dose of pomalidomide combined with dexamethasone in subjects with previously- treated light-chain amyloidosis
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
27 participants
Primary outcome timeframe
one month
Results posted on
2020-09-22
Participant Flow
Protocol was open to accrual between January 2012 and August 2016. Participants were recruited from within the amyloidosis clinic within Boston Medical Center.
Participant milestones
| Measure |
Experimental: Phase I - Cohort 1 (Pomalidomide 2mg)
Drug: Pomalidomide Cohort 1 = 2 mg/day, Days 1-28
Drug: Dexamethasone 10-20 mg on days 1, 8, 15, and 22
|
Experimental: Phase I - Cohort 2 (Pomalidomide 3mg)
Drug: Pomalidomide Cohort 12= 3 mg/day, Days 1-28
Drug: Dexamethasone 10-20 mg on days 1, 8, 15, and 22
|
Experimental: Phase I - Cohort 3 (Pomalidomide 4mg)
Drug: Pomalidomide Cohort 3 = 4 mg/day, Days 1-28
Drug: Dexamethasone 10-20 mg on days 1, 8, 15, and 22
|
Experimental: Phase II Expansion- Maximum Tolerated Dose
Drug: Pomalidomide Expansion Phase - Maximum Tolerated Dose = 4 mg/day, Days 1-28
Drug: Dexamethasone 10-20 mg on days 1, 8, 15, and 22
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
3
|
6
|
12
|
|
Overall Study
Dose Limiting Toxicity
|
0
|
0
|
6
|
12
|
|
Overall Study
Response to Maximal Tolerated Dose
|
0
|
0
|
3
|
6
|
|
Overall Study
COMPLETED
|
5
|
3
|
6
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Experimental: Phase I - Cohort 1 (Pomalidomide 2mg)
Drug: Pomalidomide Cohort 1 = 2 mg/day, Days 1-28
Drug: Dexamethasone 10-20 mg on days 1, 8, 15, and 22
|
Experimental: Phase I - Cohort 2 (Pomalidomide 3mg)
Drug: Pomalidomide Cohort 12= 3 mg/day, Days 1-28
Drug: Dexamethasone 10-20 mg on days 1, 8, 15, and 22
|
Experimental: Phase I - Cohort 3 (Pomalidomide 4mg)
Drug: Pomalidomide Cohort 3 = 4 mg/day, Days 1-28
Drug: Dexamethasone 10-20 mg on days 1, 8, 15, and 22
|
Experimental: Phase II Expansion- Maximum Tolerated Dose
Drug: Pomalidomide Expansion Phase - Maximum Tolerated Dose = 4 mg/day, Days 1-28
Drug: Dexamethasone 10-20 mg on days 1, 8, 15, and 22
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Phase I/II Trial of Pomalidomide and Dexamethasone in Subjects With Previously-Treated AL Amyloidosis
Baseline characteristics by cohort
| Measure |
Phase I - Cohort 1 (Pomalidomide 2mg) Plus Dexam
n=6 Participants
Pomalidomide: Cohort 1 = 2 mg/day, Cohort 2 = 3 mg/day, Cohort 3 = 4 mg/day: Days 1-28
Dexamethasone: 10-20 mg on days 1, 8, 15, and 22
|
Phase I - Cohort 2 (Pomalidomide 3mg)
n=3 Participants
Pomalidomide 3 mg/day on days 1-28 plus dexamethasone 10-20 mg on days 1-21 of a 28 day cycle
|
Phase I - Cohort 3 (Pomalidomide 4mg)
n=6 Participants
Pomalidomide 4 mg/day on days 1-28 plus dexamethasone 10-20 mg on days 1-21 of a 28 day cycle
|
Phase II Expansion- (Pomalidomide 4mg) Plus Dexa
n=12 Participants
Pomalidomide 4 mg/day (MTD) on days 1-28 plus dexamethasone 10-20 mg on days 1-21 of a 28 day cycle
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Prior treatments
1 to 2 prior treatments
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Prior treatments
greater than 2 prior treatments
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: one monthNumber of patients in Phase I cohort 1 experiencing dose-limiting toxicity at the 2 milligram dose of pomalidomide combined with dexamethasone in subjects with previously- treated light-chain amyloidosis
Outcome measures
| Measure |
Pom Plus Dex
n=6 Participants
Pomalidomide dexamethasone
Pomalidomide: Cohort 1 = 2 mg/day, Cohort 2 = 3 mg/day, Cohort 3 = 4 mg/day: Days 1-28
Dexamethasone: 10-20 mg on days 1, 8, 15, and 22
|
|---|---|
|
Assessing Dose-limiting Toxicity to Determine Maximal Tolerated Dosage at 2 Milligram Dose
|
0 Participants
|
PRIMARY outcome
Timeframe: One monthNumber of patients in Phase I cohort 2 experiencing dose limiting toxicity in the 3 milligram dose level, cohort 2.
Outcome measures
| Measure |
Pom Plus Dex
n=3 Participants
Pomalidomide dexamethasone
Pomalidomide: Cohort 1 = 2 mg/day, Cohort 2 = 3 mg/day, Cohort 3 = 4 mg/day: Days 1-28
Dexamethasone: 10-20 mg on days 1, 8, 15, and 22
|
|---|---|
|
Assessing Dose-limiting Toxicity to Determine Maximal Tolerated Dosage at 3 Milligram Dose
|
0 Participants
|
PRIMARY outcome
Timeframe: One monthNumber of patients in Phase I cohort 3 experiencing dose-limiting toxicity at the 4 milligram dose for participants within the third dose cohort
Outcome measures
| Measure |
Pom Plus Dex
n=6 Participants
Pomalidomide dexamethasone
Pomalidomide: Cohort 1 = 2 mg/day, Cohort 2 = 3 mg/day, Cohort 3 = 4 mg/day: Days 1-28
Dexamethasone: 10-20 mg on days 1, 8, 15, and 22
|
|---|---|
|
Assessing Dose-limiting Toxicity to Determine Maximal Tolerated Dosage at 4 Milligram Dose
|
1 Participants
|
SECONDARY outcome
Timeframe: one yearPopulation: Number of evaluable patients treated at the maximal tolerated dose of 4mg including the Phase I cohort 3 participants and the Phase II expansion participants
Number of participants with a response to treatment at that maximal tolerated dose (including partial, very good, or complete responses)
Outcome measures
| Measure |
Pom Plus Dex
n=18 Participants
Pomalidomide dexamethasone
Pomalidomide: Cohort 1 = 2 mg/day, Cohort 2 = 3 mg/day, Cohort 3 = 4 mg/day: Days 1-28
Dexamethasone: 10-20 mg on days 1, 8, 15, and 22
|
|---|---|
|
Response to the Maximal Tolerated Dose
|
10 Participants
|
Adverse Events
Phase I - Cohort 1 (Pomalidomide 2mg)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 1 deaths
Phase I - Cohort 2 (Pomalidomide 3mg)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase I - Cohort 3 (Pomalidomide 4mg)
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase II Expansion- Maximum Tolerated Dose
Serious events: 3 serious events
Other events: 12 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Phase I - Cohort 1 (Pomalidomide 2mg)
n=6 participants at risk
Drug: Pomalidomide Cohort 1 = 2 mg/day, Days 1-28
Drug: Dexamethasone 10-20 mg on days 1, 8, 15, and 22
|
Phase I - Cohort 2 (Pomalidomide 3mg)
n=3 participants at risk
Drug: Pomalidomide Cohort 2 = 3 mg/day, Days 1-28
Drug: Dexamethasone 10-20 mg on days 1, 8, 15, and 22
|
Phase I - Cohort 3 (Pomalidomide 4mg)
n=6 participants at risk
Drug: Pomalidomide Cohort 3 = 4 mg/day, Days 1-28
Drug: Dexamethasone 10-20 mg on days 1, 8, 15, and 22
|
Phase II Expansion- Maximum Tolerated Dose
n=12 participants at risk
Drug: Pomalidomide Maximum Tolerated Dose = 4 mg/day, Days 1-28
Drug: Dexamethasone 10-20 mg on days 1, 8, 15, and 22
|
|---|---|---|---|---|
|
Infections and infestations
Upper respiratory infection
|
16.7%
1/6 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
16.7%
1/6 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
16.7%
2/12 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Infections and infestations
sepsis
|
16.7%
1/6 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
2/6 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
16.7%
2/12 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Cardiac disorders
myocardial infarction
|
16.7%
1/6 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/6 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/12 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
Other adverse events
| Measure |
Phase I - Cohort 1 (Pomalidomide 2mg)
n=6 participants at risk
Drug: Pomalidomide Cohort 1 = 2 mg/day, Days 1-28
Drug: Dexamethasone 10-20 mg on days 1, 8, 15, and 22
|
Phase I - Cohort 2 (Pomalidomide 3mg)
n=3 participants at risk
Drug: Pomalidomide Cohort 2 = 3 mg/day, Days 1-28
Drug: Dexamethasone 10-20 mg on days 1, 8, 15, and 22
|
Phase I - Cohort 3 (Pomalidomide 4mg)
n=6 participants at risk
Drug: Pomalidomide Cohort 3 = 4 mg/day, Days 1-28
Drug: Dexamethasone 10-20 mg on days 1, 8, 15, and 22
|
Phase II Expansion- Maximum Tolerated Dose
n=12 participants at risk
Drug: Pomalidomide Maximum Tolerated Dose = 4 mg/day, Days 1-28
Drug: Dexamethasone 10-20 mg on days 1, 8, 15, and 22
|
|---|---|---|---|---|
|
Investigations
White blood cell count decreased
|
50.0%
3/6 • Number of events 3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
16.7%
1/6 • Number of events 4 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
83.3%
10/12 • Number of events 15 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Respiratory, thoracic and mediastinal disorders
wheezing
|
0.00%
0/6 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
1/3 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
2/6 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/12 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
General disorders
weakness
|
50.0%
3/6 • Number of events 3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
1/3 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
50.0%
3/6 • Number of events 4 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
4/12 • Number of events 5 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Gastrointestinal disorders
vomiting
|
16.7%
1/6 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
50.0%
3/6 • Number of events 3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
16.7%
2/12 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Eye disorders
visual blurring
|
66.7%
4/6 • Number of events 4 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
16.7%
1/6 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
25.0%
3/12 • Number of events 3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Renal and urinary disorders
urinary urgency
|
0.00%
0/6 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/6 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
8.3%
1/12 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Renal and urinary disorders
urinary incontinence
|
16.7%
1/6 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
1/3 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/6 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
16.7%
2/12 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Renal and urinary disorders
urinary frequency
|
66.7%
4/6 • Number of events 5 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
66.7%
4/6 • Number of events 5 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/12 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Renal and urinary disorders
urinary hesitancy
|
16.7%
1/6 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
16.7%
1/6 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
8.3%
1/12 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Metabolism and nutrition disorders
hyperuricemia
|
0.00%
0/6 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
1/3 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
50.0%
3/6 • Number of events 12 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
41.7%
5/12 • Number of events 6 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Infections and infestations
upper respiratory infection
|
33.3%
2/6 • Number of events 3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
1/3 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
66.7%
4/6 • Number of events 6 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
25.0%
3/12 • Number of events 4 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Metabolism and nutrition disorders
hypertriglyceridemia
|
0.00%
0/6 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
1/3 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
2/6 • Number of events 4 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
16.7%
2/12 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Nervous system disorders
tremor
|
0.00%
0/6 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
66.7%
2/3 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
16.7%
1/6 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
4/12 • Number of events 5 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Ear and labyrinth disorders
tinnitus
|
0.00%
0/6 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
1/3 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/6 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
16.7%
2/12 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Investigations
platelet count decreased
|
33.3%
2/6 • Number of events 5 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
2/6 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
4/12 • Number of events 9 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Respiratory, thoracic and mediastinal disorders
sore throat
|
16.7%
1/6 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
16.7%
1/6 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
8.3%
1/12 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Skin and subcutaneous tissue disorders
rash
|
0.00%
0/6 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
1/3 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
50.0%
3/6 • Number of events 3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
41.7%
5/12 • Number of events 7 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Skin and subcutaneous tissue disorders
pruritis
|
16.7%
1/6 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
1/3 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/6 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
25.0%
3/12 • Number of events 3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
16.7%
1/6 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
16.7%
1/6 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
8.3%
1/12 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Nervous system disorders
peripheral sensory neuropathy
|
0.00%
0/6 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
1/3 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
16.7%
1/6 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
8.3%
1/12 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Nervous system disorders
paresthesia
|
16.7%
1/6 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
1/3 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
16.7%
1/6 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
16.7%
2/12 • Number of events 3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Cardiac disorders
palpitations
|
33.3%
2/6 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
1/3 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/6 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
8.3%
1/12 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Musculoskeletal and connective tissue disorders
back pain
|
16.7%
1/6 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
1/3 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
50.0%
3/6 • Number of events 3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/12 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/6 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
2/6 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
41.7%
5/12 • Number of events 6 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Musculoskeletal and connective tissue disorders
pain-extremity
|
16.7%
1/6 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
66.7%
2/3 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
2/6 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
16.7%
2/12 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
0.00%
0/6 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
1/3 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/6 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/12 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Investigations
neutrophil count decreased
|
16.7%
1/6 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
1/3 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
100.0%
6/6 • Number of events 9 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
75.0%
9/12 • Number of events 16 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Gastrointestinal disorders
nausea
|
33.3%
2/6 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
66.7%
2/3 • Number of events 3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
50.0%
3/6 • Number of events 5 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
4/12 • Number of events 4 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
0.00%
0/6 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/6 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
16.7%
2/12 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Musculoskeletal and connective tissue disorders
muscle disorder - cramping
|
16.7%
1/6 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
1/3 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
66.7%
4/6 • Number of events 4 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
25.0%
3/12 • Number of events 3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Psychiatric disorders
mood alteration
|
50.0%
3/6 • Number of events 3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
2/6 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
16.7%
2/12 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Investigations
lymphocyte count decreased
|
0.00%
0/6 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
83.3%
5/6 • Number of events 18 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
41.7%
5/12 • Number of events 9 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Nervous system disorders
lightheadedness
|
16.7%
1/6 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
66.7%
2/3 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
16.7%
1/6 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
16.7%
2/12 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Investigations
leukocyte count decreased
|
0.00%
0/6 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
1/3 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
66.7%
4/6 • Number of events 5 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
8.3%
1/12 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Psychiatric disorders
insomnia
|
16.7%
1/6 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
2/6 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
4/12 • Number of events 5 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Skin and subcutaneous tissue disorders
infection - skin
|
0.00%
0/6 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
1/3 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
16.7%
1/6 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/12 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Vascular disorders
hypotension
|
16.7%
1/6 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
16.7%
1/6 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
8.3%
1/12 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Metabolism and nutrition disorders
hypophosphatemia
|
16.7%
1/6 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
2/6 • Number of events 4 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
25.0%
3/12 • Number of events 9 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Metabolism and nutrition disorders
hyponatremia
|
50.0%
3/6 • Number of events 9 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
2/6 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
4/12 • Number of events 4 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Metabolism and nutrition disorders
hypoalbuminemia
|
33.3%
2/6 • Number of events 3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
1/3 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
83.3%
5/6 • Number of events 7 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
16.7%
2/12 • Number of events 3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Endocrine disorders
hyperthyroidism
|
0.00%
0/6 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
2/6 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
8.3%
1/12 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Metabolism and nutrition disorders
hyperkalemia
|
50.0%
3/6 • Number of events 6 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
50.0%
3/6 • Number of events 4 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
8.3%
1/12 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Metabolism and nutrition disorders
hyperglycemia
|
0.00%
0/6 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
1/3 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
100.0%
6/6 • Number of events 12 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
16.7%
2/12 • Number of events 4 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Respiratory, thoracic and mediastinal disorders
hoarseness
|
33.3%
2/6 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
100.0%
3/3 • Number of events 3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
2/6 • Number of events 3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
4/12 • Number of events 4 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
General disorders
fever
|
16.7%
1/6 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
83.3%
5/6 • Number of events 5 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
16.7%
2/12 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
General disorders
fatigue
|
50.0%
3/6 • Number of events 4 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
66.7%
2/3 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
66.7%
4/6 • Number of events 8 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
66.7%
8/12 • Number of events 10 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
33.3%
2/6 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/6 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
16.7%
2/12 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
General disorders
edema - limbs
|
0.00%
0/6 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
2/6 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
58.3%
7/12 • Number of events 9 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
16.7%
1/6 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
66.7%
2/3 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
83.3%
5/6 • Number of events 10 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
50.0%
6/12 • Number of events 6 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Nervous system disorders
dysgeusia
|
0.00%
0/6 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/6 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
41.7%
5/12 • Number of events 5 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Skin and subcutaneous tissue disorders
dry skin
|
33.3%
2/6 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
1/3 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
2/6 • Number of events 3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/12 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Nervous system disorders
dizziness
|
0.00%
0/6 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
1/3 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
2/6 • Number of events 3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
16.7%
2/12 • Number of events 4 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Gastrointestinal disorders
diarrhea
|
66.7%
4/6 • Number of events 4 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
1/3 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
50.0%
3/6 • Number of events 5 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
25.0%
3/12 • Number of events 4 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Investigations
creatinine elevated
|
66.7%
4/6 • Number of events 8 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
1/3 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
83.3%
5/6 • Number of events 8 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
41.7%
5/12 • Number of events 10 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
16.7%
1/6 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
66.7%
2/3 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
2/6 • Number of events 4 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
4/12 • Number of events 6 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Gastrointestinal disorders
constipation
|
66.7%
4/6 • Number of events 5 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
100.0%
3/3 • Number of events 3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
50.0%
3/6 • Number of events 3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
4/12 • Number of events 4 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Renal and urinary disorders
chronic kidney disease
|
33.3%
2/6 • Number of events 4 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
2/6 • Number of events 5 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
8.3%
1/12 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
16.7%
1/6 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
25.0%
3/12 • Number of events 5 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Investigations
anemia
|
83.3%
5/6 • Number of events 8 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
1/3 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
66.7%
4/6 • Number of events 15 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
50.0%
6/12 • Number of events 8 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Metabolism and nutrition disorders
anorexia
|
16.7%
1/6 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
1/3 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
2/6 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
25.0%
3/12 • Number of events 3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Investigations
alkaline phosphatase increased
|
16.7%
1/6 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
1/3 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
2/6 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
25.0%
3/12 • Number of events 5 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Gastrointestinal disorders
abdominal bloating
|
33.3%
2/6 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/6 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/12 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Injury, poisoning and procedural complications
bruising
|
0.00%
0/6 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
2/6 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
8.3%
1/12 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Investigations
hypokalemia
|
16.7%
1/6 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
2/6 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/12 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Renal and urinary disorders
hematuria
|
0.00%
0/6 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
1/3 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
2/6 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/12 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Cardiac disorders
heart failure
|
16.7%
1/6 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
2/6 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/12 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Ear and labyrinth disorders
hearing impaired
|
0.00%
0/6 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
1/3 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
16.7%
1/6 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
16.7%
2/12 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Nervous system disorders
headache
|
16.7%
1/6 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/6 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
16.7%
2/12 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Gastrointestinal disorders
hemorrhoids
|
16.7%
1/6 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
1/3 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
16.7%
1/6 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
16.7%
2/12 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Gastrointestinal disorders
dyspepsia
|
0.00%
0/6 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
1/3 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
16.7%
1/6 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/12 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Gastrointestinal disorders
dry mouth
|
0.00%
0/6 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
16.7%
1/6 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
8.3%
1/12 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Cardiac disorders
chest pain
|
16.7%
1/6 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/6 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
8.3%
1/12 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
General disorders
chills
|
0.00%
0/6 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
2/6 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/12 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Investigations
aspartate aminotransferase increased
|
83.3%
5/6 • Number of events 5 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
2/6 • Number of events 2 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
33.3%
4/12 • Number of events 4 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Psychiatric disorders
anxiety
|
16.7%
1/6 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
16.7%
1/6 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/12 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
|
Vascular disorders
hypertension
|
16.7%
1/6 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/3 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
16.7%
1/6 • Number of events 1 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
0.00%
0/12 • 6 years
Adverse events for each participant were assessed at all visits while treatment continued through 30 days post last dose. 6 years represents the time from first participant initiating treatment though last participant completing treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place