Trial Outcomes & Findings for MCS110 With BRAF/MEK Inhibition in Patients With Melanoma (NCT NCT03455764)
NCT ID: NCT03455764
Last Updated: 2024-07-31
Results Overview
A DLT was defined as an adverse event that (a) was possibly, probably, or definitely related to the study medication regimen and (b) experienced during the first cycle of treatment, and (c) met any of the following criteria: ≥ Grade 3 non-hematological toxicity; grade 3 thrombocytopenia with clinically significant bleeding; grade 4 thrombocytopenia; ≥ grade 3 febrile neutropenia; grade 4 anemia; holding of any study medication due to toxicity for a period of greater than 8 consecutive days or two separate periods of any duration during the first cycle, any other significant toxicity deemed by the principal investigator to be dose limiting.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
6 participants
Primary outcome timeframe
Participants were followed up to 21 days.
Results posted on
2024-07-31
Participant Flow
Participants were enrolled from September 2018 to July 2019.
Phase 2 never enrolled any patients because the company stopped development of the drug after the 6 patients were enrolled to the phase 1 portion. No further patients were enrolled to either arm after that.
Participant milestones
| Measure |
MCS110+ Trametinib + Dabrafenib [Phase I Dose Level 1]
MCS110 2.5 mg/kg was administered intravenously every 3 weeks. Dabrafenib 150mg is given orally every 12 hours. Trametinib 2mg was given orally daily.
|
MCS110+ Trametinib + Dabrafenib [Phase I Dose Level -1]
MCS110 1.25 mg/kg was administered intravenously every 3 weeks. Dabrafenib 150mg is given orally every 12 hours. Trametinib 2mg was given orally daily.
|
MCS110+ Trametinib + Dabrafenib [Phase I Dose Level 2]
MCS110 5 mg/kg was administered intravenously every 3 weeks. Dabrafenib 150mg is given orally every 12 hours. Trametinib 2mg was given orally daily.
|
MCS110+ Trametinib + Dabrafenib [Phase I Dose Level 3]
MCS110 10 mg/kg was administered intravenously every 3 weeks. Dabrafenib 150mg is given orally every 12 hours. Trametinib 2mg was given orally daily.
|
MCS110 + Trametinib + Dabrafenib [Phase 2]
MCS110 at recommended phase 2 dose level was administered intravenously every 3 weeks.
Dabrafenib 150mg is given orally every 12 hours. Trametinib 2mg was given orally daily.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
0
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
MCS110+ Trametinib + Dabrafenib [Phase I Dose Level 1]
MCS110 2.5 mg/kg was administered intravenously every 3 weeks. Dabrafenib 150mg is given orally every 12 hours. Trametinib 2mg was given orally daily.
|
MCS110+ Trametinib + Dabrafenib [Phase I Dose Level -1]
MCS110 1.25 mg/kg was administered intravenously every 3 weeks. Dabrafenib 150mg is given orally every 12 hours. Trametinib 2mg was given orally daily.
|
MCS110+ Trametinib + Dabrafenib [Phase I Dose Level 2]
MCS110 5 mg/kg was administered intravenously every 3 weeks. Dabrafenib 150mg is given orally every 12 hours. Trametinib 2mg was given orally daily.
|
MCS110+ Trametinib + Dabrafenib [Phase I Dose Level 3]
MCS110 10 mg/kg was administered intravenously every 3 weeks. Dabrafenib 150mg is given orally every 12 hours. Trametinib 2mg was given orally daily.
|
MCS110 + Trametinib + Dabrafenib [Phase 2]
MCS110 at recommended phase 2 dose level was administered intravenously every 3 weeks.
Dabrafenib 150mg is given orally every 12 hours. Trametinib 2mg was given orally daily.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Disease Progression
|
4
|
0
|
0
|
0
|
0
|
|
Overall Study
On Treatment
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
MCS110 With BRAF/MEK Inhibition in Patients With Melanoma
Baseline characteristics by cohort
| Measure |
MCS110+ Trametinib + Dabrafenib [Phase I Dose Level 1]
n=6 Participants
MCS110 2.5 mg/kg was administered intravenously every 3 weeks. Dabrafenib 150mg was given orally every 12 hours. Trametinib 2mg was given orally daily.
|
MCS110 + Trametinib + Dabrafenib [Phase 2]
MCS110 at recommended phase 2 dose level was administered intravenously every 3 weeks.
Dabrafenib 150mg was given orally every 12 hours. Trametinib 2mg was given orally daily.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.7 years
STANDARD_DEVIATION 17.1 • n=5 Participants
|
—
|
53.7 years
STANDARD_DEVIATION 17.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
—
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
—
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
—
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
—
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
—
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Participants were followed up to 21 days.Population: The study was terminated before Phase 2 was initiated.
A DLT was defined as an adverse event that (a) was possibly, probably, or definitely related to the study medication regimen and (b) experienced during the first cycle of treatment, and (c) met any of the following criteria: ≥ Grade 3 non-hematological toxicity; grade 3 thrombocytopenia with clinically significant bleeding; grade 4 thrombocytopenia; ≥ grade 3 febrile neutropenia; grade 4 anemia; holding of any study medication due to toxicity for a period of greater than 8 consecutive days or two separate periods of any duration during the first cycle, any other significant toxicity deemed by the principal investigator to be dose limiting.
Outcome measures
| Measure |
MCS110+ Trametinib + Dabrafenib
n=6 Participants
* For Phase 1 MCS110 2.5mg/kg will be administered intravenously every 3 weeks.
* Dabrafenib 150mg is given orally every 12 hours.
* Trametinib 2mg is given orally daily
|
|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLT) [Phase I]
|
1 Participants
|
PRIMARY outcome
Timeframe: Participants were followed up to 21 days.The trial used 3+3 design to determine maximum tolerated dose (MTD), escalating on 0/3 or 1/6 DLTs, and de-escalating if two DLTs were encountered. See subsequent primary outcome measure for the DLT definition. MTD was the highest dose level at which 0/3 or 1/6 subjects experienced a DLT.
Outcome measures
| Measure |
MCS110+ Trametinib + Dabrafenib
n=6 Participants
* For Phase 1 MCS110 2.5mg/kg will be administered intravenously every 3 weeks.
* Dabrafenib 150mg is given orally every 12 hours.
* Trametinib 2mg is given orally daily
|
|---|---|
|
Maximum Tolerated Dose of MCS110 [Phase I]
|
2.5 mg/kg
|
SECONDARY outcome
Timeframe: Participants were followed up to 30 months.ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
Outcome measures
| Measure |
MCS110+ Trametinib + Dabrafenib
n=6 Participants
* For Phase 1 MCS110 2.5mg/kg will be administered intravenously every 3 weeks.
* Dabrafenib 150mg is given orally every 12 hours.
* Trametinib 2mg is given orally daily
|
|---|---|
|
Overall Response Rate (ORR) [Phase I]
|
16.7 percentage of participants
Interval 1.0 to 58.0
|
SECONDARY outcome
Timeframe: Participants were followed up to 30 months.PFS is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Participants alive without PD were censored at the earliest of the date of the last disease evaluation or start of new anticancer therapy. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated.
Outcome measures
| Measure |
MCS110+ Trametinib + Dabrafenib
n=6 Participants
* For Phase 1 MCS110 2.5mg/kg will be administered intravenously every 3 weeks.
* Dabrafenib 150mg is given orally every 12 hours.
* Trametinib 2mg is given orally daily
|
|---|---|
|
Median Progression Free Survival [Phase I]
|
2.3 months
Interval 1.3 to
Insufficient number progressed during the time of observation.
|
POST_HOC outcome
Timeframe: Participants were followed up to 30 months.Grade 3 adverse event (AE) rate was defined as the proportion of patients who experienced grade 3 adverse events based on Common Terminology Criteria for Adverse Events (CTCAE) version 4 (see standard source vocabulary as per AE module). Descriptions of severity (grade) are dependent on AE type with a scale of 1 (least severe) to 5. Please refer to https://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm Per their definitions: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
Outcome measures
| Measure |
MCS110+ Trametinib + Dabrafenib
n=6 Participants
* For Phase 1 MCS110 2.5mg/kg will be administered intravenously every 3 weeks.
* Dabrafenib 150mg is given orally every 12 hours.
* Trametinib 2mg is given orally daily
|
|---|---|
|
Grade 3 Adverse Events Rate
|
0.83 proportion of participants
Interval 0.42 to 0.99
|
POST_HOC outcome
Timeframe: Participants were followed up to 30 months.Population: Zero patients were enrolled in the Phase 2 portion of the study.
OS based on Kaplan-Meier method is defined as the time from registration to death due to any cause, or censored at date last known alive.
Outcome measures
| Measure |
MCS110+ Trametinib + Dabrafenib
n=6 Participants
* For Phase 1 MCS110 2.5mg/kg will be administered intravenously every 3 weeks.
* Dabrafenib 150mg is given orally every 12 hours.
* Trametinib 2mg is given orally daily
|
|---|---|
|
Median Overall Survival (OS)
|
5.3 months
Interval 3.4 to
Insufficient number died during the time of observation.
|
Adverse Events
MCS110+ Trametinib + Dabrafenib [Phase I Dose Level I]
Serious events: 1 serious events
Other events: 6 other events
Deaths: 3 deaths
MCS110 + Trametinib + Dabrafenib Phase 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MCS110+ Trametinib + Dabrafenib [Phase I Dose Level I]
n=6 participants at risk
* For Phase 1 MCS110 2.5mg/kg will be administered intravenously every 3 weeks.
* Dabrafenib 150mg is given orally every 12 hours.
* Trametinib 2mg is given orally daily
|
MCS110 + Trametinib + Dabrafenib Phase 2
* MCS110 will be administered intravenously every 3 weeks. The Dosage will be determine by the DLT of Phase 1
* Dabrafenib 150mg is given orally every 12 hours.
* Trametinib 2mg is given orally daily
|
|---|---|---|
|
Investigations
Alkaline phosphatase increased
|
16.7%
1/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
Other adverse events
| Measure |
MCS110+ Trametinib + Dabrafenib [Phase I Dose Level I]
n=6 participants at risk
* For Phase 1 MCS110 2.5mg/kg will be administered intravenously every 3 weeks.
* Dabrafenib 150mg is given orally every 12 hours.
* Trametinib 2mg is given orally daily
|
MCS110 + Trametinib + Dabrafenib Phase 2
* MCS110 will be administered intravenously every 3 weeks. The Dosage will be determine by the DLT of Phase 1
* Dabrafenib 150mg is given orally every 12 hours.
* Trametinib 2mg is given orally daily
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
4/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Cardiac disorders
Pericardial effusion
|
16.7%
1/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Endocrine disorders
Hypothyroidism
|
16.7%
1/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Eye disorders
Blurred vision
|
16.7%
1/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Eye disorders
Conjunctivitis
|
16.7%
1/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Eye disorders
Watering eyes
|
16.7%
1/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Eye disorders
Eye disorders - Other, specify
|
33.3%
2/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
2/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
4/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
4/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
16.7%
1/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
16.7%
1/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
4/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
General disorders
Chills
|
66.7%
4/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
General disorders
Edema limbs
|
16.7%
1/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
General disorders
Fatigue
|
50.0%
3/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
General disorders
Fever
|
83.3%
5/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
General disorders
Flu like symptoms
|
33.3%
2/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
General disorders
Infusion related reaction
|
33.3%
2/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
General disorders
Malaise
|
16.7%
1/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
General disorders
Pain
|
16.7%
1/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
16.7%
1/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
2/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Investigations
Alkaline phosphatase increased
|
50.0%
3/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Investigations
Aspartate aminotransferase increased
|
100.0%
6/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Investigations
CPK increased
|
83.3%
5/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
16.7%
1/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Investigations
Creatinine increased
|
33.3%
2/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Investigations
GGT increased
|
16.7%
1/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Investigations
Lipase increased
|
16.7%
1/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Investigations
Neutrophil count decreased
|
16.7%
1/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Investigations
Weight gain
|
16.7%
1/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Investigations
Weight loss
|
33.3%
2/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Investigations
White blood cell decreased
|
33.3%
2/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Investigations
Investigations - Other, specify
|
16.7%
1/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
3/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
2/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Metabolism and nutrition disorders
Dehydration
|
50.0%
3/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
16.7%
1/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
16.7%
1/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
33.3%
2/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
50.0%
3/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.3%
2/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
66.7%
4/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
16.7%
1/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
33.3%
2/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
2/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
16.7%
1/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
2/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
16.7%
1/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Nervous system disorders
Dizziness
|
33.3%
2/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Nervous system disorders
Headache
|
50.0%
3/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Nervous system disorders
Memory impairment
|
16.7%
1/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Nervous system disorders
Paresthesia
|
16.7%
1/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Nervous system disorders
Syncope
|
16.7%
1/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
16.7%
1/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Renal and urinary disorders
Acute kidney injury
|
16.7%
1/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Renal and urinary disorders
Urinary frequency
|
16.7%
1/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Renal and urinary disorders
Urine discoloration
|
16.7%
1/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
16.7%
1/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
16.7%
1/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
3/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
1/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
16.7%
1/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
33.3%
2/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
16.7%
1/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
16.7%
1/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
16.7%
1/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
50.0%
3/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
|
Vascular disorders
Hot flashes
|
16.7%
1/6 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
—
0/0 • Participants were followed up to 30 months.
A serious adverse event is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All other remaining adverse events will be considered as other adverse event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place