Trial Outcomes & Findings for Nivolumab/Ipilimumab Plus Cabozantinib in Patients With Unresectable Advanced Melanoma (NCT NCT04091750)
NCT ID: NCT04091750
Last Updated: 2025-02-25
Results Overview
The PFS rate for nivolumab/ipilimumab plus cabozantinib in patients with unresectable advanced melanoma using imRECIST.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
1 year
Results posted on
2025-02-25
Participant Flow
Participant milestones
| Measure |
Single Arm
Induction phase:
Nivolumab 3mg/kg IV plus Ipilimumab 1mg/kg IV every 3 weeks x 4 cycles (12 week period)
Cabozantinib 40mg PO daily for 12 weeks
Maintenance phase:
Nivolumab 480mg IV every 4 weeks for up to 92 weeks
Cabozantinib 40mg PO daily for up to 92 weeks
Maintenance therapy will continue for up to 92 weeks to complete 2 years total of treatment if tolerating therapy well and disease is controlled.
Nivolumab: Induction: 3mg/kg IV every 3 weeks x 4 cycles
Maintenance: 480mg IV every 4 weeks for up to 92 weeks
Ipilimumab: Induction: 1mg/kg IV every 3 weeks x 4 cycles
Cabozantinib: Induction and Maintenance: 40mg PO daily
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Single Arm
Induction phase:
Nivolumab 3mg/kg IV plus Ipilimumab 1mg/kg IV every 3 weeks x 4 cycles (12 week period)
Cabozantinib 40mg PO daily for 12 weeks
Maintenance phase:
Nivolumab 480mg IV every 4 weeks for up to 92 weeks
Cabozantinib 40mg PO daily for up to 92 weeks
Maintenance therapy will continue for up to 92 weeks to complete 2 years total of treatment if tolerating therapy well and disease is controlled.
Nivolumab: Induction: 3mg/kg IV every 3 weeks x 4 cycles
Maintenance: 480mg IV every 4 weeks for up to 92 weeks
Ipilimumab: Induction: 1mg/kg IV every 3 weeks x 4 cycles
Cabozantinib: Induction and Maintenance: 40mg PO daily
|
|---|---|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Nivolumab/Ipilimumab Plus Cabozantinib in Patients With Unresectable Advanced Melanoma
Baseline characteristics by cohort
| Measure |
Single Arm
n=14 Participants
Induction phase:
Nivolumab 3mg/kg IV plus Ipilimumab 1mg/kg IV every 3 weeks x 4 cycles (12 week period)
Cabozantinib 40mg PO daily for 12 weeks
Maintenance phase:
Nivolumab 480mg IV every 4 weeks for up to 92 weeks
Cabozantinib 40mg PO daily for up to 92 weeks
Maintenance therapy will continue for up to 92 weeks to complete 2 years total of treatment if tolerating therapy well and disease is controlled.
Nivolumab: Induction: 3mg/kg IV every 3 weeks x 4 cycles
Maintenance: 480mg IV every 4 weeks for up to 92 weeks
Ipilimumab: Induction: 1mg/kg IV every 3 weeks x 4 cycles
Cabozantinib: Induction and Maintenance: 40mg PO daily
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearThe PFS rate for nivolumab/ipilimumab plus cabozantinib in patients with unresectable advanced melanoma using imRECIST.
Outcome measures
| Measure |
Single Arm
n=14 Participants
Induction phase:
Nivolumab 3mg/kg IV plus Ipilimumab 1mg/kg IV every 3 weeks x 4 cycles (12 week period)
Cabozantinib 40mg PO daily for 12 weeks
Maintenance phase:
Nivolumab 480mg IV every 4 weeks for up to 92 weeks
Cabozantinib 40mg PO daily for up to 92 weeks
Maintenance therapy will continue for up to 92 weeks to complete 2 years total of treatment if tolerating therapy well and disease is controlled.
Nivolumab: Induction: 3mg/kg IV every 3 weeks x 4 cycles
Maintenance: 480mg IV every 4 weeks for up to 92 weeks
Ipilimumab: Induction: 1mg/kg IV every 3 weeks x 4 cycles
Cabozantinib: Induction and Maintenance: 40mg PO daily
|
|---|---|
|
The Progression Free Survival (PFS) for Nivolumab/Ipilimumab Plus Cabozantinib in Patients With Unresectable Advanced Melanoma.
|
6 Participants
|
SECONDARY outcome
Timeframe: 1 yearThe ORR by imRECIST of nivolumab/ipilimumab plus cabozantinib in patients with unresectable advanced melanoma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 yearsThe median and 3 year OS rate of patients with unresectable advanced melanoma treated with nivolumab/ipilimumab plus cabozantinib.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsThe rate of all grade and grade 3-5 adverse events and the rate of discontinuation of study drug(s) due to adverse events.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 yearsMeasured in terms of ORR, PFS, and OS.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 yearsMeasured in terms of ORR, PFS, and OS.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearMeasured by the change in immune cell populations, CD31 vascularization, and MHC class I expression by multiplex immunofluorescense (IF) between baseline and on treatment tumor specimens.
Outcome measures
Outcome data not reported
Adverse Events
Single Arm
Serious events: 9 serious events
Other events: 14 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Single Arm
n=14 participants at risk
Induction phase:
Nivolumab 3mg/kg IV plus Ipilimumab 1mg/kg IV every 3 weeks x 4 cycles (12 week period)
Cabozantinib 40mg PO daily for 12 weeks
Maintenance phase:
Nivolumab 480mg IV every 4 weeks for up to 92 weeks
Cabozantinib 40mg PO daily for up to 92 weeks
Maintenance therapy will continue for up to 92 weeks to complete 2 years total of treatment if tolerating therapy well and disease is controlled.
Nivolumab: Induction: 3mg/kg IV every 3 weeks x 4 cycles
Maintenance: 480mg IV every 4 weeks for up to 92 weeks
Ipilimumab: Induction: 1mg/kg IV every 3 weeks x 4 cycles
Cabozantinib: Induction and Maintenance: 40mg PO daily
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Cardiac disorders
Myocardial infarction
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Cardiac disorders
Heart failure
|
14.3%
2/14 • Number of events 2 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Cardiac disorders
Supraventricular tachycardia
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Eye disorders
Eye disorders - Other, specify
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
1/14 • Number of events 3 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Gastrointestinal disorders
Dysphagia
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
General disorders
Fatigue
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
General disorders
Fever
|
14.3%
2/14 • Number of events 3 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
General disorders
Non-cardiac chest pain
|
7.1%
1/14 • Number of events 2 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Infections and infestations
Catheter related infection
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Infections and infestations
Urinary tract infection
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Infections and infestations
Upper respiratory infection
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Infections and infestations
Sepsis
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Metabolism and nutrition disorders
Dehydration
|
14.3%
2/14 • Number of events 2 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Metabolism and nutrition disorders
Arthralgia
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Nervous system disorders
Paresthesia
|
14.3%
2/14 • Number of events 2 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Nervous system disorders
Dizziness
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Nervous system disorders
Syncope
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Psychiatric disorders
Confusion
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Renal and urinary disorders
Acute kidney injury
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
7.1%
1/14 • Number of events 2 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
Other adverse events
| Measure |
Single Arm
n=14 participants at risk
Induction phase:
Nivolumab 3mg/kg IV plus Ipilimumab 1mg/kg IV every 3 weeks x 4 cycles (12 week period)
Cabozantinib 40mg PO daily for 12 weeks
Maintenance phase:
Nivolumab 480mg IV every 4 weeks for up to 92 weeks
Cabozantinib 40mg PO daily for up to 92 weeks
Maintenance therapy will continue for up to 92 weeks to complete 2 years total of treatment if tolerating therapy well and disease is controlled.
Nivolumab: Induction: 3mg/kg IV every 3 weeks x 4 cycles
Maintenance: 480mg IV every 4 weeks for up to 92 weeks
Ipilimumab: Induction: 1mg/kg IV every 3 weeks x 4 cycles
Cabozantinib: Induction and Maintenance: 40mg PO daily
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
42.9%
6/14 • Number of events 22 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Gastrointestinal disorders
Dysphagia
|
7.1%
1/14 • Number of events 2 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Gastrointestinal disorders
Enterocolitis
|
7.1%
1/14 • Number of events 2 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
21.4%
3/14 • Number of events 4 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Gastrointestinal disorders
Mucositis oral
|
7.1%
1/14 • Number of events 2 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Gastrointestinal disorders
Nausea
|
21.4%
3/14 • Number of events 5 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Gastrointestinal disorders
Oral pain
|
14.3%
2/14 • Number of events 3 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Gastrointestinal disorders
Vomiting
|
21.4%
3/14 • Number of events 10 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
General disorders
Edema face
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
General disorders
Edema limbs
|
21.4%
3/14 • Number of events 4 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
General disorders
Fatigue
|
42.9%
6/14 • Number of events 9 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
General disorders
Fever
|
21.4%
3/14 • Number of events 3 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
General disorders
Pain
|
21.4%
3/14 • Number of events 3 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Immune system disorders
Allergic reaction
|
14.3%
2/14 • Number of events 2 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Infections and infestations
Bronchial infection
|
14.3%
2/14 • Number of events 2 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Immune system disorders
Paronychia
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Infections and infestations
Shingles
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Infections and infestations
Skin infection
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Infections and infestations
Soft tissue infection
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Infections and infestations
Tooth infection
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Infections and infestations
Upper respiratory infection
|
14.3%
2/14 • Number of events 2 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Infections and infestations
Urinary tract infection
|
28.6%
4/14 • Number of events 5 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Infections and infestations
Wound infection
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Injury, poisoning and procedural complications
Burn
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Investigations
Alanine aminotransferase increased
|
57.1%
8/14 • Number of events 16 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Investigations
Alkaline phosphatase increased
|
21.4%
3/14 • Number of events 6 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Investigations
Aspartate aminotransferase increased
|
57.1%
8/14 • Number of events 18 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Investigations
CPK increased
|
14.3%
2/14 • Number of events 21 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Investigations
Creatinine increased
|
35.7%
5/14 • Number of events 7 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Investigations
GGT increased
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Investigations
Lipase increased
|
14.3%
2/14 • Number of events 6 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Investigations
Neutrophil count decreased
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Investigations
Serum amylase increased
|
21.4%
3/14 • Number of events 4 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Investigations
Weight loss
|
14.3%
2/14 • Number of events 2 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Investigations
White blood cell decreased
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Metabolism and nutrition disorders
Anorexia
|
21.4%
3/14 • Number of events 4 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Metabolism and nutrition disorders
Dehydration
|
21.4%
3/14 • Number of events 5 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
21.4%
3/14 • Number of events 5 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
28.6%
4/14 • Number of events 15 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
21.4%
3/14 • Number of events 3 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Eye disorders
Eye disorders - Other, specify
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Eye disorders
Watering eyes
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Gastrointestinal disorders
Abdominal distension
|
14.3%
2/14 • Number of events 2 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
2/14 • Number of events 8 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Gastrointestinal disorders
Belching
|
7.1%
1/14 • Number of events 2 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Gastrointestinal disorders
Bloating
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Gastrointestinal disorders
Constipation
|
21.4%
3/14 • Number of events 4 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Ear and labyrinth disorders
Vertigo
|
7.1%
1/14 • Number of events 2 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Endocrine disorders
Adrenal insufficiency
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Endocrine disorders
Hyperthyroidism
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Endocrine disorders
Hypoparathyroidism
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Endocrine disorders
Hypophysitis
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Endocrine disorders
Hypothyroidism
|
14.3%
2/14 • Number of events 2 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Blood and lymphatic system disorders
Anemia
|
7.1%
1/14 • Number of events 2 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Cardiac disorders
Atrial fibrillation
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Cardiac disorders
Myocardial infarction
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
28.6%
4/14 • Number of events 4 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
7.1%
1/14 • Number of events 3 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
14.3%
2/14 • Number of events 2 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
14.3%
2/14 • Number of events 4 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.1%
1/14 • Number of events 2 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.3%
2/14 • Number of events 2 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Nervous system disorders
Dizziness
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Nervous system disorders
Dysesthesia
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Nervous system disorders
Dysgeusia
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Nervous system disorders
Headache
|
21.4%
3/14 • Number of events 6 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Nervous system disorders
Paresthesia
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
14.3%
2/14 • Number of events 2 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Nervous system disorders
Presyncope
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Nervous system disorders
Syncope
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Psychiatric disorders
Depression
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Psychiatric disorders
Insomnia
|
28.6%
4/14 • Number of events 4 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Psychiatric disorders
Irritability
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Renal and urinary disorders
Hematuria
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Renal and urinary disorders
Proteinuria
|
21.4%
3/14 • Number of events 6 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Renal and urinary disorders
Renal calculi
|
14.3%
2/14 • Number of events 2 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
2/14 • Number of events 2 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
21.4%
3/14 • Number of events 3 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
14.3%
2/14 • Number of events 2 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
7.1%
1/14 • Number of events 2 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
50.0%
7/14 • Number of events 15 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
2/14 • Number of events 2 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
35.7%
5/14 • Number of events 6 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
14.3%
2/14 • Number of events 2 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Vascular disorders
Hot flashes
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Vascular disorders
Hypertension
|
21.4%
3/14 • Number of events 4 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Vascular disorders
Hypotension
|
14.3%
2/14 • Number of events 2 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Vascular disorders
Phlebitis
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Vascular disorders
Thromboembolic event
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Vascular disorders
Vascular disorder- Other, specify
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
|
Vascular disorders
Vascular disorder- other, specify
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from after informed consent through 30 days after the decision to discontinue study treatment (approximately 2 years); All Cause Mortality was collected after discontinuation of treatment until death during a long term follow up period (approximately 4 years).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place