Trial Outcomes & Findings for A Phase 2 Study of Durvalumab in Combination With Tremelimumab in Malignant Pleural Mesothelioma (NCT NCT03075527)
NCT ID: NCT03075527
Last Updated: 2026-01-08
Results Overview
Overall Response Rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) as best response on treatment based on RECIST v1.1 criteria.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
ORR was assessed every 8 weeks from Cycle 1 Day 1 until date of documented disease progression or death. The median treatment duration is 1.91 months with range (0.00 months - 23.46 months).
Results posted on
2026-01-08
Participant Flow
Patients were enrolled from April 2017 to August 2018.
Participant milestones
| Measure |
Tremelimumab + Durvalumab
Subjects will receive durvalumab and tremelimumab both via intravenous infusion once per day for every 28 day cycles (+ 7 days). Participants will receive tremelimumab for up to 4 cycles (4 doses). Beginning with cycle 5 day 1, subjects will continue to receive durvalumab alone, until clinical or radiological progression.
Tremelimumab: Tremelimumab blocks a receptor on immune cells that normally suppresses immune attack.
Durvalumab: Durvalumab is a drug that blocks a protein often produced by cancer cells or surrounding cells to suppress immune cells from attacking cancer cells.
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
Tremelimumab + Durvalumab
Subjects will receive durvalumab and tremelimumab both via intravenous infusion once per day for every 28 day cycles (+ 7 days). Participants will receive tremelimumab for up to 4 cycles (4 doses). Beginning with cycle 5 day 1, subjects will continue to receive durvalumab alone, until clinical or radiological progression.
Tremelimumab: Tremelimumab blocks a receptor on immune cells that normally suppresses immune attack.
Durvalumab: Durvalumab is a drug that blocks a protein often produced by cancer cells or surrounding cells to suppress immune cells from attacking cancer cells.
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|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Physician Decision
|
3
|
|
Overall Study
Progression/Relapse
|
14
|
Baseline Characteristics
A Phase 2 Study of Durvalumab in Combination With Tremelimumab in Malignant Pleural Mesothelioma
Baseline characteristics by cohort
| Measure |
Tremelimumab + Durvalumab
n=19 Participants
Subjects will receive durvalumab and tremelimumab both via intravenous infusion once per day for every 28 day cycles (+ 7 days). Participants will receive tremelimumab for up to 4 cycles (4 doses). Beginning with cycle 5 day 1, subjects will continue to receive durvalumab alone, until clinical or radiological progression.
Tremelimumab: Tremelimumab blocks a receptor on immune cells that normally suppresses immune attack.
Durvalumab: Durvalumab is a drug that blocks a protein often produced by cancer cells or surrounding cells to suppress immune cells from attacking cancer cells.
|
|---|---|
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Age, Customized
Age
|
69 years
n=18 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=18 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=18 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=18 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=18 Participants
|
PRIMARY outcome
Timeframe: ORR was assessed every 8 weeks from Cycle 1 Day 1 until date of documented disease progression or death. The median treatment duration is 1.91 months with range (0.00 months - 23.46 months).Population: The analysis population is comprised of eligible and treated patients.
Overall Response Rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) as best response on treatment based on RECIST v1.1 criteria.
Outcome measures
| Measure |
Tremelimumab + Durvalumab
n=19 Participants
Subjects will receive durvalumab and tremelimumab both via intravenous infusion once per day for every 28 day cycles (+ 7 days). Participants will receive tremelimumab for up to 4 cycles (4 doses). Beginning with cycle 5 day 1, subjects will continue to receive durvalumab alone, until clinical or radiological progression.
Tremelimumab: Tremelimumab blocks a receptor on immune cells that normally suppresses immune attack.
Durvalumab: Durvalumab is a drug that blocks a protein often produced by cancer cells or surrounding cells to suppress immune cells from attacking cancer cells.
|
|---|---|
|
Overall Response Rate (ORR)
|
0.105 proportion of paticipants
Interval 0.045 to 0.229
|
SECONDARY outcome
Timeframe: OS is assessed from date of registration until date of death on-treatment or during follow-up. Survival data collection in long-term follow-up every 3-4 months. Median follow-up for survival is of 27.33 months with range (0.76 months - 50.40 months).Population: The analysis population is comprised of eligible and treated patients.
OS based on the Kaplan-Meier method is defined as the time from study entry to death or censored at date last known alive.
Outcome measures
| Measure |
Tremelimumab + Durvalumab
n=19 Participants
Subjects will receive durvalumab and tremelimumab both via intravenous infusion once per day for every 28 day cycles (+ 7 days). Participants will receive tremelimumab for up to 4 cycles (4 doses). Beginning with cycle 5 day 1, subjects will continue to receive durvalumab alone, until clinical or radiological progression.
Tremelimumab: Tremelimumab blocks a receptor on immune cells that normally suppresses immune attack.
Durvalumab: Durvalumab is a drug that blocks a protein often produced by cancer cells or surrounding cells to suppress immune cells from attacking cancer cells.
|
|---|---|
|
Median Overall Survival (OS)
|
9.76 months
Interval 7.2 to 29.2
|
SECONDARY outcome
Timeframe: Participants were evaluated for response every 8 weeks on study and in long-term survival followed-up every 3-4 months. Median follow-up for survival is of 27.33 months with range (0.76 months - 50.40 months).Population: The analysis population is comprised of eligible and treated patients.
PFS based on the Kaplan-Meier method is defined as the duration between randomization and documented disease progression (PD) defined per RECIST 1.1 criteria. or death, or is censored at time of last disease assessment.
Outcome measures
| Measure |
Tremelimumab + Durvalumab
n=19 Participants
Subjects will receive durvalumab and tremelimumab both via intravenous infusion once per day for every 28 day cycles (+ 7 days). Participants will receive tremelimumab for up to 4 cycles (4 doses). Beginning with cycle 5 day 1, subjects will continue to receive durvalumab alone, until clinical or radiological progression.
Tremelimumab: Tremelimumab blocks a receptor on immune cells that normally suppresses immune attack.
Durvalumab: Durvalumab is a drug that blocks a protein often produced by cancer cells or surrounding cells to suppress immune cells from attacking cancer cells.
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|---|---|
|
Median Progression Free Survival (PFS)
|
3.42 months
Interval 2.79 to 5.72
|
SECONDARY outcome
Timeframe: The median of treatment duration is 1.91 months with range (0.00 months - 23.46 months).Population: This analysis dataset is comprised of all patients who had a CR or PR on treatment.
DOR is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (or censored at the date of last disease evaluation).
Outcome measures
| Measure |
Tremelimumab + Durvalumab
n=2 Participants
Subjects will receive durvalumab and tremelimumab both via intravenous infusion once per day for every 28 day cycles (+ 7 days). Participants will receive tremelimumab for up to 4 cycles (4 doses). Beginning with cycle 5 day 1, subjects will continue to receive durvalumab alone, until clinical or radiological progression.
Tremelimumab: Tremelimumab blocks a receptor on immune cells that normally suppresses immune attack.
Durvalumab: Durvalumab is a drug that blocks a protein often produced by cancer cells or surrounding cells to suppress immune cells from attacking cancer cells.
|
|---|---|
|
Median Duration of Response (DOR)
|
2.07 months
Interval 2.07 to
The upper bound of the 80% CI for median DOR is NA due to insufficient events.
|
SECONDARY outcome
Timeframe: Toxicity is assessed from the time of first dose of study medication until the participant comes off study. The median of treatment duration is 1.91 months with range (0.00 months - 23.46 months).Population: This analysis dataset is comprised of all eligible and treated patients.
All grade 4-5 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv4.03 that are not resolved in accordance with treatment guidelines were counted. Rate is the proportion of treated participants experiencing at least one of these adverse events as defined during the time of observation.
Outcome measures
| Measure |
Tremelimumab + Durvalumab
n=19 Participants
Subjects will receive durvalumab and tremelimumab both via intravenous infusion once per day for every 28 day cycles (+ 7 days). Participants will receive tremelimumab for up to 4 cycles (4 doses). Beginning with cycle 5 day 1, subjects will continue to receive durvalumab alone, until clinical or radiological progression.
Tremelimumab: Tremelimumab blocks a receptor on immune cells that normally suppresses immune attack.
Durvalumab: Durvalumab is a drug that blocks a protein often produced by cancer cells or surrounding cells to suppress immune cells from attacking cancer cells.
|
|---|---|
|
Grade 4-5 Treatment-related Toxicity Rate
|
0.158 proportion of paticipants
Interval 0.061 to 0.322
|
Adverse Events
Tremelimumab + Durvalumab
Serious events: 4 serious events
Other events: 19 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Tremelimumab + Durvalumab
n=19 participants at risk
Subjects will receive durvalumab and tremelimumab both via intravenous infusion once per day for every 28 day cycles (+ 7 days). Participants will receive tremelimumab for up to 4 cycles (4 doses). Beginning with cycle 5 day 1, subjects will continue to receive durvalumab alone, until clinical or radiological progression.
Tremelimumab: Tremelimumab blocks a receptor on immune cells that normally suppresses immune attack.
Durvalumab: Durvalumab is a drug that blocks a protein often produced by cancer cells or surrounding cells to suppress immune cells from attacking cancer cells.
|
|---|---|
|
Gastrointestinal disorders
Dysphagia
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
10.5%
2/19 • Number of events 2 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Musculoskeletal and connective tissue disorders
Spinal Cord Compression
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
General disorders
Death NOS
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
Other adverse events
| Measure |
Tremelimumab + Durvalumab
n=19 participants at risk
Subjects will receive durvalumab and tremelimumab both via intravenous infusion once per day for every 28 day cycles (+ 7 days). Participants will receive tremelimumab for up to 4 cycles (4 doses). Beginning with cycle 5 day 1, subjects will continue to receive durvalumab alone, until clinical or radiological progression.
Tremelimumab: Tremelimumab blocks a receptor on immune cells that normally suppresses immune attack.
Durvalumab: Durvalumab is a drug that blocks a protein often produced by cancer cells or surrounding cells to suppress immune cells from attacking cancer cells.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
10.5%
2/19 • Number of events 2 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Cardiac disorders
Sinus bradycardia
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Cardiac disorders
Sinus tachycardia
|
10.5%
2/19 • Number of events 2 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Congenital, familial and genetic disorders
Congenital, familial and genetic disorders - Other, specify
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Ear and labyrinth disorders
Vertigo
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Endocrine disorders
Hyperthyroidism
|
15.8%
3/19 • Number of events 3 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Endocrine disorders
Hypothyroidism
|
10.5%
2/19 • Number of events 2 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Gastrointestinal disorders
Ascites
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Gastrointestinal disorders
Bloating
|
10.5%
2/19 • Number of events 2 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Gastrointestinal disorders
Constipation
|
21.1%
4/19 • Number of events 4 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Gastrointestinal disorders
Diarrhea
|
15.8%
3/19 • Number of events 3 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Gastrointestinal disorders
Dysphagia
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Gastrointestinal disorders
Nausea
|
15.8%
3/19 • Number of events 3 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Gastrointestinal disorders
Vomiting
|
15.8%
3/19 • Number of events 3 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
General disorders
Chills
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
General disorders
Edema limbs
|
15.8%
3/19 • Number of events 3 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
General disorders
Fatigue
|
36.8%
7/19 • Number of events 7 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
10.5%
2/19 • Number of events 2 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
General disorders
Localized edema
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
General disorders
Non-cardiac chest pain
|
10.5%
2/19 • Number of events 2 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
General disorders
Pain
|
15.8%
3/19 • Number of events 3 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Infections and infestations
Lung infection
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Infections and infestations
Rash pustular
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Infections and infestations
Upper respiratory infection
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Investigations
Alkaline phosphatase increased
|
10.5%
2/19 • Number of events 2 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Investigations
Creatinine increased
|
15.8%
3/19 • Number of events 3 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Investigations
Investigations - Other, specify
|
10.5%
2/19 • Number of events 2 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Investigations
Lipase increased
|
21.1%
4/19 • Number of events 4 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Investigations
Neutrophil count decreased
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Investigations
Serum amylase increased
|
15.8%
3/19 • Number of events 3 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Investigations
Weight gain
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Investigations
Weight loss
|
10.5%
2/19 • Number of events 2 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Investigations
White blood cell decreased
|
10.5%
2/19 • Number of events 2 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Metabolism and nutrition disorders
Anorexia
|
15.8%
3/19 • Number of events 3 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
15.8%
3/19 • Number of events 3 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
31.6%
6/19 • Number of events 6 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
21.1%
4/19 • Number of events 4 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
10.5%
2/19 • Number of events 2 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.5%
2/19 • Number of events 2 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.5%
2/19 • Number of events 2 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
15.8%
3/19 • Number of events 3 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Nervous system disorders
Dizziness
|
10.5%
2/19 • Number of events 2 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Psychiatric disorders
Anxiety
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Psychiatric disorders
Insomnia
|
15.8%
3/19 • Number of events 3 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.1%
4/19 • Number of events 4 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
15.8%
3/19 • Number of events 3 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal mucositis
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.5%
2/19 • Number of events 2 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
15.8%
3/19 • Number of events 3 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
21.1%
4/19 • Number of events 4 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
10.5%
2/19 • Number of events 2 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Vascular disorders
Hypotension
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Vascular disorders
Thromboembolic event
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Investigations
Alanine aminotransferase increased
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
|
|
Investigations
Aspartate aminotransferase increased
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place