Trial Outcomes & Findings for Study of Pembrolizumab and Cabozantinib in Patients With Metastatic Renal Cell Carcinoma (NCT NCT03149822)
NCT ID: NCT03149822
Last Updated: 2025-03-13
Results Overview
Measured through the complete response (CR) + partial response (PR)\] of pembrolizumab and cabozantinib when administered in combination in subjects with locally advanced or metastatic renal cell carcinoma. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
45 participants
Primary outcome timeframe
Beginning of study to end of study, up to 5 years
Results posted on
2025-03-13
Participant Flow
Participant milestones
| Measure |
Phase 1: Pembrolizumab 200 mg Plus Cabozantinib 40mg
Pembrolizumab 200 mg intravenous (IV) infusion on day 1 of each 21-day cycle in combination with cabozantinib 40 mg orally once daily until disease progression, unacceptable toxicity, or consent withdrawal.
Cabozantinib: Pharmaceutical form: tablets Route of administration: oral
Pembrolizumab: Pharmaceutical form: solution Route of administration: injection
|
Phase 1: Pembrolizumab 200 mg Plus Cabozantinib 60mg
Pembrolizumab 200 mg intravenous (IV) infusion on day 1 of each 21-day cycle in combination with cabozantinib 60 mg orally once daily until disease progression, unacceptable toxicity, or consent withdrawal.
Cabozantinib: Pharmaceutical form: tablets Route of administration: oral
Pembrolizumab: Pharmaceutical form: solution Route of administration: injection
|
Phase 2: Pembrolizumab 200 mg Plus Cabozantinib at the RP2D
Pembrolizumab 200 mg intravenous (IV) infusion on day 1 of each 21-day cycle in combination with cabozantinib at the RP2D orally once daily for up to 35 cycles, until disease progression, unacceptable toxicity, or consent withdrawal. All participants who stop pembrolizumab after 35 cycles with SD or better may be eligible for up to an additional 17 cycles (approximately 1 year) of pembrolizumab treatment if they progress after stopping pembrolizumab from the initial treatment phase.
Cabozantinib: Pharmaceutical form: tablets Route of administration: oral
Pembrolizumab: Pharmaceutical form: solution Route of administration: injection
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
3
|
37
|
|
Overall Study
COMPLETED
|
5
|
3
|
37
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Pembrolizumab and Cabozantinib in Patients With Metastatic Renal Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Phase 1: Pembrolizumab 200 mg Plus Cabozantinib 40mg
n=5 Participants
Pembrolizumab 200 mg intravenous (IV) infusion on day 1 of each 21-day cycle in combination with cabozantinib 40 mg orally once daily until disease progression, unacceptable toxicity, or consent withdrawal.
Cabozantinib: Pharmaceutical form: tablets Route of administration: oral
Pembrolizumab: Pharmaceutical form: solution Route of administration: injection
|
Phase 1: Pembrolizumab 200 mg Plus Cabozantinib 60mg
n=3 Participants
Pembrolizumab 200 mg intravenous (IV) infusion on day 1 of each 21-day cycle in combination with cabozantinib 60 mg orally once daily until disease progression, unacceptable toxicity, or consent withdrawal.
Cabozantinib: Pharmaceutical form: tablets Route of administration: oral
Pembrolizumab: Pharmaceutical form: solution Route of administration: injection
|
Phase 2: Pembrolizumab 200 mg Plus Cabozantinib at the RP2D
n=37 Participants
Pembrolizumab 200 mg intravenous (IV) infusion on day 1 of each 21-day cycle in combination with cabozantinib at the RP2D orally once daily for up to 35 cycles, until disease progression, unacceptable toxicity, or consent withdrawal. All participants who stop pembrolizumab after 35 cycles with SD or better may be eligible for up to an additional 17 cycles (approximately 1 year) of pembrolizumab treatment if they progress after stopping pembrolizumab from the initial treatment phase.
Cabozantinib: Pharmaceutical form: tablets Route of administration: oral
Pembrolizumab: Pharmaceutical form: solution Route of administration: injection
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
27 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
|
Age, Continuous
|
55.2 years
STANDARD_DEVIATION 9.8 • n=99 Participants
|
48.7 years
STANDARD_DEVIATION 9.6 • n=107 Participants
|
61.7 years
STANDARD_DEVIATION 11.5 • n=206 Participants
|
60.1 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
33 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
41 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
40 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=99 Participants
|
3 participants
n=107 Participants
|
37 participants
n=206 Participants
|
45 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Beginning of study to end of study, up to 5 yearsPopulation: Total RCC patients who were evaluable for response at the dose level
Measured through the complete response (CR) + partial response (PR)\] of pembrolizumab and cabozantinib when administered in combination in subjects with locally advanced or metastatic renal cell carcinoma. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
All Patients Treated at the RP2D of Pembrolizumab 200 mg IM Q3W Plus Cabozantinib 60 mg PO QD
n=38 Participants
Pembrolizumab 200 mg intravenous (IV) infusion on day 1 of each 21-day cycle in combination with cabozantinib at the RP2D orally once daily for up to 35 cycles, until disease progression, unacceptable toxicity, or consent withdrawal. All participants who stop pembrolizumab after 35 cycles with SD or better may be eligible for up to an additional 17 cycles (approximately 1 year) of pembrolizumab treatment if they progress after stopping pembrolizumab from the initial treatment phase.
Cabozantinib: Pharmaceutical form: tablets Route of administration: oral
Pembrolizumab: Pharmaceutical form: solution Route of administration: injection
|
Phase 1 Dose Escalation Cohort: Pembrolizumab 200 mg IV Q3W Plus Cabozantinib 40mg PO QD
n=5 Participants
Pembrolizumab 200 mg intravenous (IV) infusion on day 1 of each 21-day cycle in combination with cabozantinib 40 mg orally once daily until disease progression, unacceptable toxicity, or consent withdrawal.
Cabozantinib: Pharmaceutical form: tablets Route of administration: oral
Pembrolizumab: Pharmaceutical form: solution Route of administration: injection
|
|---|---|---|
|
Efficacy of Pembrolizumab and Cabozantinib Based on Objective Response Rate
|
65.8 % of patients
Interval 49.9 to 78.8
|
0 % of patients
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Throughout Cycle 1, up to 21 daysPopulation: There were 8 total patients enrolled in phase I cohorts of the study (5 in cohort 1 (PEM 200/CABO 40) and 3 in cohort 2 (PEM 200/CABO 60). Among the 5 patients in cohort 1, only 3 were evaluable for DLT and MTD. In total, 6 patients in phase I were evaluable for DLT and MTD.
* The MTD is defined as the highest dose level with no more than 1 DLT reported in 6 DLT-evaluable subjects. * The Recommended Phase 2 Dose (RP2D) of cabozantinib will be selected based on the clinical data and will not exceed the MTD. If \< 2/6 subjects experience a DLT at 60 mg daily during dose escalation, then 60 mg daily will be considered the RP2D. If ≥ 2/6 subjects experience DLTs at 60 mg daily, and ≤ 1/6 subjects experience a DLT at 40 mg daily, then 40 mg daily will be considered the RP2D. The dose of pembrolizumab will be constant at 200 mg IV every 3 weeks.
Outcome measures
| Measure |
All Patients Treated at the RP2D of Pembrolizumab 200 mg IM Q3W Plus Cabozantinib 60 mg PO QD
n=6 Participants
Pembrolizumab 200 mg intravenous (IV) infusion on day 1 of each 21-day cycle in combination with cabozantinib at the RP2D orally once daily for up to 35 cycles, until disease progression, unacceptable toxicity, or consent withdrawal. All participants who stop pembrolizumab after 35 cycles with SD or better may be eligible for up to an additional 17 cycles (approximately 1 year) of pembrolizumab treatment if they progress after stopping pembrolizumab from the initial treatment phase.
Cabozantinib: Pharmaceutical form: tablets Route of administration: oral
Pembrolizumab: Pharmaceutical form: solution Route of administration: injection
|
Phase 1 Dose Escalation Cohort: Pembrolizumab 200 mg IV Q3W Plus Cabozantinib 40mg PO QD
Pembrolizumab 200 mg intravenous (IV) infusion on day 1 of each 21-day cycle in combination with cabozantinib 40 mg orally once daily until disease progression, unacceptable toxicity, or consent withdrawal.
Cabozantinib: Pharmaceutical form: tablets Route of administration: oral
Pembrolizumab: Pharmaceutical form: solution Route of administration: injection
|
|---|---|---|
|
Maximally Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)
|
60 mg
|
—
|
SECONDARY outcome
Timeframe: Throughout Cycle 1, up to 21 daysPopulation: Total patients enrolled in phase I of the study who were evaluable for DLTs.
Assessed through Common Terminology Criteria for Adverse Events (CTCAE) v 4.0. Dose Limiting Toxicity (DLT) was defined as any of the following events occurring during the DLT assessment window (21 days) and is assessed by the investigator to be likely related to study treatment (pembrolizumab and/or cabozantinib). * Grade ≥ 3 non-hematologic, non-hepatic adverse events * Grade 3 nausea, vomiting, or diarrhea lasting \>72 hours despite maximal medical therapy. * Grade ≥ 4 neutropenia (ANC \< 500 cells/μL) lasting \> 7 days * Grade ≥ 3 febrile neutropenia * Grade ≥ 4 anemia * Grade ≥ 4 thrombocytopenia, or Grade 3 thrombocytopenia associated with clinically significant bleeding * Grade ≥ 3 elevation of serum hepatic transaminase (ALT or AST). * Grade ≥ 3 elevation of serum total bilirubin. * ALT or AST \> 3 × upper limit of normal (ULN) AND total bilirubin \>2 × ULN will require permanent treatment discontinuation.
Outcome measures
| Measure |
All Patients Treated at the RP2D of Pembrolizumab 200 mg IM Q3W Plus Cabozantinib 60 mg PO QD
n=3 Participants
Pembrolizumab 200 mg intravenous (IV) infusion on day 1 of each 21-day cycle in combination with cabozantinib at the RP2D orally once daily for up to 35 cycles, until disease progression, unacceptable toxicity, or consent withdrawal. All participants who stop pembrolizumab after 35 cycles with SD or better may be eligible for up to an additional 17 cycles (approximately 1 year) of pembrolizumab treatment if they progress after stopping pembrolizumab from the initial treatment phase.
Cabozantinib: Pharmaceutical form: tablets Route of administration: oral
Pembrolizumab: Pharmaceutical form: solution Route of administration: injection
|
Phase 1 Dose Escalation Cohort: Pembrolizumab 200 mg IV Q3W Plus Cabozantinib 40mg PO QD
n=3 Participants
Pembrolizumab 200 mg intravenous (IV) infusion on day 1 of each 21-day cycle in combination with cabozantinib 40 mg orally once daily until disease progression, unacceptable toxicity, or consent withdrawal.
Cabozantinib: Pharmaceutical form: tablets Route of administration: oral
Pembrolizumab: Pharmaceutical form: solution Route of administration: injection
|
|---|---|---|
|
Dose Limiting Toxicities
|
0 events
|
0 events
|
SECONDARY outcome
Timeframe: Beginning of study to end of study, or death, whichever comes first, up to 5 yearsPopulation: All 40 patients treated at the RP2D were included in the survival analyses.
Measured as the time it takes for an occurrence of documented disease progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
All Patients Treated at the RP2D of Pembrolizumab 200 mg IM Q3W Plus Cabozantinib 60 mg PO QD
n=40 Participants
Pembrolizumab 200 mg intravenous (IV) infusion on day 1 of each 21-day cycle in combination with cabozantinib at the RP2D orally once daily for up to 35 cycles, until disease progression, unacceptable toxicity, or consent withdrawal. All participants who stop pembrolizumab after 35 cycles with SD or better may be eligible for up to an additional 17 cycles (approximately 1 year) of pembrolizumab treatment if they progress after stopping pembrolizumab from the initial treatment phase.
Cabozantinib: Pharmaceutical form: tablets Route of administration: oral
Pembrolizumab: Pharmaceutical form: solution Route of administration: injection
|
Phase 1 Dose Escalation Cohort: Pembrolizumab 200 mg IV Q3W Plus Cabozantinib 40mg PO QD
Pembrolizumab 200 mg intravenous (IV) infusion on day 1 of each 21-day cycle in combination with cabozantinib 40 mg orally once daily until disease progression, unacceptable toxicity, or consent withdrawal.
Cabozantinib: Pharmaceutical form: tablets Route of administration: oral
Pembrolizumab: Pharmaceutical form: solution Route of administration: injection
|
|---|---|---|
|
Progression-Free Survival
|
10.45 months
Interval 6.25 to 14.63
|
—
|
SECONDARY outcome
Timeframe: Beginning of study to end of study, or death, whichever comes first, up to 5 yearsPopulation: All 40 patients treated at the RP2D were included in the survival analyses.
Measured as the time it takes for an occurrence of death due to any cause
Outcome measures
| Measure |
All Patients Treated at the RP2D of Pembrolizumab 200 mg IM Q3W Plus Cabozantinib 60 mg PO QD
n=40 Participants
Pembrolizumab 200 mg intravenous (IV) infusion on day 1 of each 21-day cycle in combination with cabozantinib at the RP2D orally once daily for up to 35 cycles, until disease progression, unacceptable toxicity, or consent withdrawal. All participants who stop pembrolizumab after 35 cycles with SD or better may be eligible for up to an additional 17 cycles (approximately 1 year) of pembrolizumab treatment if they progress after stopping pembrolizumab from the initial treatment phase.
Cabozantinib: Pharmaceutical form: tablets Route of administration: oral
Pembrolizumab: Pharmaceutical form: solution Route of administration: injection
|
Phase 1 Dose Escalation Cohort: Pembrolizumab 200 mg IV Q3W Plus Cabozantinib 40mg PO QD
Pembrolizumab 200 mg intravenous (IV) infusion on day 1 of each 21-day cycle in combination with cabozantinib 40 mg orally once daily until disease progression, unacceptable toxicity, or consent withdrawal.
Cabozantinib: Pharmaceutical form: tablets Route of administration: oral
Pembrolizumab: Pharmaceutical form: solution Route of administration: injection
|
|---|---|---|
|
Overall Survival
|
30.81 months
Interval 24.23 to 40.0
|
—
|
SECONDARY outcome
Timeframe: Beginning of study to end of study, or death, whichever comes first, up to 5 yearsPopulation: All Evaluable Patients Treated at Pembrolizumab 200 mg IV Q3W + Cabozantinib 60 mg PO QD
DCR is the sum of the complete response, partial response, and stable disease rates
Outcome measures
| Measure |
All Patients Treated at the RP2D of Pembrolizumab 200 mg IM Q3W Plus Cabozantinib 60 mg PO QD
n=38 Participants
Pembrolizumab 200 mg intravenous (IV) infusion on day 1 of each 21-day cycle in combination with cabozantinib at the RP2D orally once daily for up to 35 cycles, until disease progression, unacceptable toxicity, or consent withdrawal. All participants who stop pembrolizumab after 35 cycles with SD or better may be eligible for up to an additional 17 cycles (approximately 1 year) of pembrolizumab treatment if they progress after stopping pembrolizumab from the initial treatment phase.
Cabozantinib: Pharmaceutical form: tablets Route of administration: oral
Pembrolizumab: Pharmaceutical form: solution Route of administration: injection
|
Phase 1 Dose Escalation Cohort: Pembrolizumab 200 mg IV Q3W Plus Cabozantinib 40mg PO QD
Pembrolizumab 200 mg intravenous (IV) infusion on day 1 of each 21-day cycle in combination with cabozantinib 40 mg orally once daily until disease progression, unacceptable toxicity, or consent withdrawal.
Cabozantinib: Pharmaceutical form: tablets Route of administration: oral
Pembrolizumab: Pharmaceutical form: solution Route of administration: injection
|
|---|---|---|
|
Disease Control Rate (DCR), AKA Clinical Benefit Rate (CBR)
|
97.4 % of patients
Interval 86.5 to 99.9
|
—
|
SECONDARY outcome
Timeframe: Time of first response as measured by RECIST 1.1 to time of progression or death, whichever comes first, up to 5 yearsPopulation: All patients evaluable for response at the RP2D of Pembrolizumab 200 mg IM Q3W plus Cabozantinib 60 mg PO QD
Duration of time that patients maintain RECIST response to treatment
Outcome measures
| Measure |
All Patients Treated at the RP2D of Pembrolizumab 200 mg IM Q3W Plus Cabozantinib 60 mg PO QD
n=38 Participants
Pembrolizumab 200 mg intravenous (IV) infusion on day 1 of each 21-day cycle in combination with cabozantinib at the RP2D orally once daily for up to 35 cycles, until disease progression, unacceptable toxicity, or consent withdrawal. All participants who stop pembrolizumab after 35 cycles with SD or better may be eligible for up to an additional 17 cycles (approximately 1 year) of pembrolizumab treatment if they progress after stopping pembrolizumab from the initial treatment phase.
Cabozantinib: Pharmaceutical form: tablets Route of administration: oral
Pembrolizumab: Pharmaceutical form: solution Route of administration: injection
|
Phase 1 Dose Escalation Cohort: Pembrolizumab 200 mg IV Q3W Plus Cabozantinib 40mg PO QD
Pembrolizumab 200 mg intravenous (IV) infusion on day 1 of each 21-day cycle in combination with cabozantinib 40 mg orally once daily until disease progression, unacceptable toxicity, or consent withdrawal.
Cabozantinib: Pharmaceutical form: tablets Route of administration: oral
Pembrolizumab: Pharmaceutical form: solution Route of administration: injection
|
|---|---|---|
|
Duration of Response
|
8.3 months
Interval 4.6 to 15.1
|
—
|
Adverse Events
Phase 1: Pembrolizumab 200 mg Plus Cabozantinib 40mg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 5 deaths
Phase 1: Pembrolizumab 200 mg Plus Cabozantinib 60mg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Phase 2: Pembrolizumab 200 mg Plus Cabozantinib at the RP2D
Serious events: 17 serious events
Other events: 37 other events
Deaths: 24 deaths
Serious adverse events
| Measure |
Phase 1: Pembrolizumab 200 mg Plus Cabozantinib 40mg
n=5 participants at risk
Pembrolizumab 200 mg intravenous (IV) infusion on day 1 of each 21-day cycle in combination with cabozantinib 40 mg orally once daily until disease progression, unacceptable toxicity, or consent withdrawal.
Cabozantinib: Pharmaceutical form: tablets Route of administration: oral
Pembrolizumab: Pharmaceutical form: solution Route of administration: injection
|
Phase 1: Pembrolizumab 200 mg Plus Cabozantinib 60mg
n=3 participants at risk
Pembrolizumab 200 mg intravenous (IV) infusion on day 1 of each 21-day cycle in combination with cabozantinib 60 mg orally once daily until disease progression, unacceptable toxicity, or consent withdrawal.
Cabozantinib: Pharmaceutical form: tablets Route of administration: oral
Pembrolizumab: Pharmaceutical form: solution Route of administration: injection
|
Phase 2: Pembrolizumab 200 mg Plus Cabozantinib at the RP2D
n=37 participants at risk
Pembrolizumab 200 mg intravenous (IV) infusion on day 1 of each 21-day cycle in combination with cabozantinib at the RP2D orally once daily for up to 35 cycles, until disease progression, unacceptable toxicity, or consent withdrawal. All participants who stop pembrolizumab after 35 cycles with SD or better may be eligible for up to an additional 17 cycles (approximately 1 year) of pembrolizumab treatment if they progress after stopping pembrolizumab from the initial treatment phase.
Cabozantinib: Pharmaceutical form: tablets Route of administration: oral
Pembrolizumab: Pharmaceutical form: solution Route of administration: injection
|
|---|---|---|---|
|
Gastrointestinal disorders
GI bleed
|
20.0%
1/5 • Number of events 1 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
2.7%
1/37 • Number of events 1 • 5 yrs and 3 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Increased cancer related pain
|
20.0%
1/5 • Number of events 1 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
0.00%
0/37 • 5 yrs and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/5 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 1 • 5 yrs and 3 months
|
0.00%
0/37 • 5 yrs and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/5 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 1 • 5 yrs and 3 months
|
5.4%
2/37 • Number of events 2 • 5 yrs and 3 months
|
|
Nervous system disorders
Reversible posterior leukoencephalopathy syndrome
|
0.00%
0/5 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 1 • 5 yrs and 3 months
|
0.00%
0/37 • 5 yrs and 3 months
|
|
Psychiatric disorders
Confusion
|
0.00%
0/5 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 1 • 5 yrs and 3 months
|
2.7%
1/37 • Number of events 1 • 5 yrs and 3 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
5.4%
2/37 • Number of events 2 • 5 yrs and 3 months
|
|
Gastrointestinal disorders
Intestinal Pneumatosis
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
2.7%
1/37 • Number of events 1 • 5 yrs and 3 months
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
2.7%
1/37 • Number of events 1 • 5 yrs and 3 months
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
2.7%
1/37 • Number of events 1 • 5 yrs and 3 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
2.7%
1/37 • Number of events 1 • 5 yrs and 3 months
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
2.7%
1/37 • Number of events 2 • 5 yrs and 3 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
2.7%
1/37 • Number of events 1 • 5 yrs and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
5.4%
2/37 • Number of events 2 • 5 yrs and 3 months
|
|
Infections and infestations
Lung infection
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
2.7%
1/37 • Number of events 1 • 5 yrs and 3 months
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
2.7%
1/37 • Number of events 1 • 5 yrs and 3 months
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
2.7%
1/37 • Number of events 1 • 5 yrs and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
2.7%
1/37 • Number of events 1 • 5 yrs and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
5.4%
2/37 • Number of events 2 • 5 yrs and 3 months
|
|
Nervous system disorders
Stroke
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
5.4%
2/37 • Number of events 2 • 5 yrs and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
2.7%
1/37 • Number of events 1 • 5 yrs and 3 months
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
2.7%
1/37 • Number of events 1 • 5 yrs and 3 months
|
|
Gastrointestinal disorders
Duodenal Hemorrhage
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
5.4%
2/37 • Number of events 2 • 5 yrs and 3 months
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
2.7%
1/37 • Number of events 1 • 5 yrs and 3 months
|
|
General disorders
Chills
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
2.7%
1/37 • Number of events 1 • 5 yrs and 3 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
2.7%
1/37 • Number of events 1 • 5 yrs and 3 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
2.7%
1/37 • Number of events 1 • 5 yrs and 3 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
5.4%
2/37 • Number of events 2 • 5 yrs and 3 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
2.7%
1/37 • Number of events 1 • 5 yrs and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
2.7%
1/37 • Number of events 1 • 5 yrs and 3 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
2.7%
1/37 • Number of events 1 • 5 yrs and 3 months
|
Other adverse events
| Measure |
Phase 1: Pembrolizumab 200 mg Plus Cabozantinib 40mg
n=5 participants at risk
Pembrolizumab 200 mg intravenous (IV) infusion on day 1 of each 21-day cycle in combination with cabozantinib 40 mg orally once daily until disease progression, unacceptable toxicity, or consent withdrawal.
Cabozantinib: Pharmaceutical form: tablets Route of administration: oral
Pembrolizumab: Pharmaceutical form: solution Route of administration: injection
|
Phase 1: Pembrolizumab 200 mg Plus Cabozantinib 60mg
n=3 participants at risk
Pembrolizumab 200 mg intravenous (IV) infusion on day 1 of each 21-day cycle in combination with cabozantinib 60 mg orally once daily until disease progression, unacceptable toxicity, or consent withdrawal.
Cabozantinib: Pharmaceutical form: tablets Route of administration: oral
Pembrolizumab: Pharmaceutical form: solution Route of administration: injection
|
Phase 2: Pembrolizumab 200 mg Plus Cabozantinib at the RP2D
n=37 participants at risk
Pembrolizumab 200 mg intravenous (IV) infusion on day 1 of each 21-day cycle in combination with cabozantinib at the RP2D orally once daily for up to 35 cycles, until disease progression, unacceptable toxicity, or consent withdrawal. All participants who stop pembrolizumab after 35 cycles with SD or better may be eligible for up to an additional 17 cycles (approximately 1 year) of pembrolizumab treatment if they progress after stopping pembrolizumab from the initial treatment phase.
Cabozantinib: Pharmaceutical form: tablets Route of administration: oral
Pembrolizumab: Pharmaceutical form: solution Route of administration: injection
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Distension
|
20.0%
1/5 • Number of events 1 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
10.8%
4/37 • Number of events 6 • 5 yrs and 3 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
40.0%
2/5 • Number of events 5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
43.2%
16/37 • Number of events 22 • 5 yrs and 3 months
|
|
Investigations
Alkaline Phosphatase increased
|
20.0%
1/5 • Number of events 1 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
18.9%
7/37 • Number of events 9 • 5 yrs and 3 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
40.0%
2/5 • Number of events 2 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
5.4%
2/37 • Number of events 2 • 5 yrs and 3 months
|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
1/5 • Number of events 2 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
29.7%
11/37 • Number of events 22 • 5 yrs and 3 months
|
|
Metabolism and nutrition disorders
Anorexia
|
40.0%
2/5 • Number of events 3 • 5 yrs and 3 months
|
66.7%
2/3 • Number of events 3 • 5 yrs and 3 months
|
64.9%
24/37 • Number of events 30 • 5 yrs and 3 months
|
|
Psychiatric disorders
Anxiety
|
20.0%
1/5 • Number of events 2 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
13.5%
5/37 • Number of events 6 • 5 yrs and 3 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
1/5 • Number of events 1 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
45.9%
17/37 • Number of events 22 • 5 yrs and 3 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
1/5 • Number of events 1 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 2 • 5 yrs and 3 months
|
32.4%
12/37 • Number of events 17 • 5 yrs and 3 months
|
|
General disorders
Chills
|
20.0%
1/5 • Number of events 1 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
21.6%
8/37 • Number of events 9 • 5 yrs and 3 months
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • Number of events 1 • 5 yrs and 3 months
|
66.7%
2/3 • Number of events 3 • 5 yrs and 3 months
|
43.2%
16/37 • Number of events 18 • 5 yrs and 3 months
|
|
Reproductive system and breast disorders
Cough
|
40.0%
2/5 • Number of events 4 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 1 • 5 yrs and 3 months
|
40.5%
15/37 • Number of events 20 • 5 yrs and 3 months
|
|
Investigations
Creatinine increased
|
40.0%
2/5 • Number of events 2 • 5 yrs and 3 months
|
66.7%
2/3 • Number of events 3 • 5 yrs and 3 months
|
16.2%
6/37 • Number of events 8 • 5 yrs and 3 months
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
2/5 • Number of events 3 • 5 yrs and 3 months
|
66.7%
2/3 • Number of events 5 • 5 yrs and 3 months
|
67.6%
25/37 • Number of events 75 • 5 yrs and 3 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
20.0%
1/5 • Number of events 1 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
24.3%
9/37 • Number of events 11 • 5 yrs and 3 months
|
|
Nervous system disorders
Dysgeusia
|
40.0%
2/5 • Number of events 6 • 5 yrs and 3 months
|
66.7%
2/3 • Number of events 2 • 5 yrs and 3 months
|
54.1%
20/37 • Number of events 31 • 5 yrs and 3 months
|
|
Ear and labyrinth disorders
Enlarged preauricular node
|
20.0%
1/5 • Number of events 1 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
0.00%
0/37 • 5 yrs and 3 months
|
|
General disorders
Edema limbs
|
40.0%
2/5 • Number of events 2 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 1 • 5 yrs and 3 months
|
32.4%
12/37 • Number of events 16 • 5 yrs and 3 months
|
|
General disorders
Fatigue
|
80.0%
4/5 • Number of events 6 • 5 yrs and 3 months
|
100.0%
3/3 • Number of events 4 • 5 yrs and 3 months
|
45.9%
17/37 • Number of events 42 • 5 yrs and 3 months
|
|
General disorders
Fever
|
20.0%
1/5 • Number of events 5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
32.4%
12/37 • Number of events 13 • 5 yrs and 3 months
|
|
Gastrointestinal disorders
Dark Stool
|
20.0%
1/5 • Number of events 1 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
13.5%
5/37 • Number of events 9 • 5 yrs and 3 months
|
|
Gastrointestinal disorders
Soft stool
|
20.0%
1/5 • Number of events 1 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
2.7%
1/37 • Number of events 1 • 5 yrs and 3 months
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
20.0%
1/5 • Number of events 3 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 1 • 5 yrs and 3 months
|
27.0%
10/37 • Number of events 16 • 5 yrs and 3 months
|
|
General disorders
Diaphragm tightness
|
20.0%
1/5 • Number of events 1 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
2.7%
1/37 • Number of events 1 • 5 yrs and 3 months
|
|
Gastrointestinal disorders
Lightheaded
|
20.0%
1/5 • Number of events 1 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
0.00%
0/37 • 5 yrs and 3 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
1/5 • Number of events 1 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 6 • 5 yrs and 3 months
|
29.7%
11/37 • Number of events 17 • 5 yrs and 3 months
|
|
Gastrointestinal disorders
Bumps under tongue
|
20.0%
1/5 • Number of events 1 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
0.00%
0/37 • 5 yrs and 3 months
|
|
Gastrointestinal disorders
Sinus irritation
|
20.0%
1/5 • Number of events 1 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
0.00%
0/37 • 5 yrs and 3 months
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/5 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 3 • 5 yrs and 3 months
|
8.1%
3/37 • Number of events 3 • 5 yrs and 3 months
|
|
General disorders
Generalized weakness
|
20.0%
1/5 • Number of events 1 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 1 • 5 yrs and 3 months
|
24.3%
9/37 • Number of events 10 • 5 yrs and 3 months
|
|
General disorders
Necrotic nasal septum
|
20.0%
1/5 • Number of events 1 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
0.00%
0/37 • 5 yrs and 3 months
|
|
Vascular disorders
Hot flashes
|
20.0%
1/5 • Number of events 1 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
0.00%
0/37 • 5 yrs and 3 months
|
|
Endocrine disorders
Hyperparathyroidism
|
20.0%
1/5 • Number of events 1 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
8.1%
3/37 • Number of events 4 • 5 yrs and 3 months
|
|
Cardiac disorders
Hypertension
|
20.0%
1/5 • Number of events 1 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 1 • 5 yrs and 3 months
|
43.2%
16/37 • Number of events 26 • 5 yrs and 3 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
20.0%
1/5 • Number of events 1 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
16.2%
6/37 • Number of events 12 • 5 yrs and 3 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
20.0%
1/5 • Number of events 4 • 5 yrs and 3 months
|
66.7%
2/3 • Number of events 9 • 5 yrs and 3 months
|
48.6%
18/37 • Number of events 50 • 5 yrs and 3 months
|
|
Infections and infestations
Gout
|
20.0%
1/5 • Number of events 3 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
0.00%
0/37 • 5 yrs and 3 months
|
|
Investigations
Increased INR
|
20.0%
1/5 • Number of events 1 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
0.00%
0/37 • 5 yrs and 3 months
|
|
Investigations
Elevated C-Telopeptide Beta-Crossed-Linked Serum
|
20.0%
1/5 • Number of events 1 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
0.00%
0/37 • 5 yrs and 3 months
|
|
Reproductive system and breast disorders
Irregular menstruation
|
20.0%
1/5 • Number of events 1 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
0.00%
0/37 • 5 yrs and 3 months
|
|
Investigations
Lymphocyte count decreased
|
20.0%
1/5 • Number of events 1 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
0.00%
0/37 • 5 yrs and 3 months
|
|
Gastrointestinal disorders
Mucositis oral
|
20.0%
1/5 • Number of events 1 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 1 • 5 yrs and 3 months
|
45.9%
17/37 • Number of events 32 • 5 yrs and 3 months
|
|
Musculoskeletal and connective tissue disorders
Bilateral Femoral pain
|
20.0%
1/5 • Number of events 1 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
0.00%
0/37 • 5 yrs and 3 months
|
|
Skin and subcutaneous tissue disorders
nail discoloration
|
20.0%
1/5 • Number of events 1 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
2.7%
1/37 • Number of events 1 • 5 yrs and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
20.0%
1/5 • Number of events 1 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
35.1%
13/37 • Number of events 19 • 5 yrs and 3 months
|
|
Gastrointestinal disorders
Nausea
|
40.0%
2/5 • Number of events 2 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 1 • 5 yrs and 3 months
|
64.9%
24/37 • Number of events 45 • 5 yrs and 3 months
|
|
Nervous system disorders
Foot hyperesthesia
|
20.0%
1/5 • Number of events 1 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
0.00%
0/37 • 5 yrs and 3 months
|
|
General disorders
Non-cardiac chest pain
|
40.0%
2/5 • Number of events 2 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 1 • 5 yrs and 3 months
|
16.2%
6/37 • Number of events 7 • 5 yrs and 3 months
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
40.0%
2/5 • Number of events 3 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 6 • 5 yrs and 3 months
|
48.6%
18/37 • Number of events 37 • 5 yrs and 3 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
20.0%
1/5 • Number of events 1 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 1 • 5 yrs and 3 months
|
5.4%
2/37 • Number of events 3 • 5 yrs and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
20.0%
1/5 • Number of events 1 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 1 • 5 yrs and 3 months
|
10.8%
4/37 • Number of events 4 • 5 yrs and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
40.0%
2/5 • Number of events 6 • 5 yrs and 3 months
|
66.7%
2/3 • Number of events 2 • 5 yrs and 3 months
|
35.1%
13/37 • Number of events 24 • 5 yrs and 3 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
1/5 • Number of events 1 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 1 • 5 yrs and 3 months
|
27.0%
10/37 • Number of events 16 • 5 yrs and 3 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
40.0%
2/5 • Number of events 3 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 2 • 5 yrs and 3 months
|
40.5%
15/37 • Number of events 34 • 5 yrs and 3 months
|
|
Cardiac disorders
Sinus tachycardia
|
20.0%
1/5 • Number of events 1 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
10.8%
4/37 • Number of events 4 • 5 yrs and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
20.0%
1/5 • Number of events 1 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
5.4%
2/37 • Number of events 2 • 5 yrs and 3 months
|
|
Skin and subcutaneous tissue disorders
Nasal ulcer
|
20.0%
1/5 • Number of events 1 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
0.00%
0/37 • 5 yrs and 3 months
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
40.0%
2/5 • Number of events 2 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 4 • 5 yrs and 3 months
|
0.00%
0/37 • 5 yrs and 3 months
|
|
Reproductive system and breast disorders
Vaginal itching/burning
|
20.0%
1/5 • Number of events 2 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
5.4%
2/37 • Number of events 3 • 5 yrs and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
20.0%
1/5 • Number of events 1 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
18.9%
7/37 • Number of events 8 • 5 yrs and 3 months
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
13.5%
5/37 • Number of events 7 • 5 yrs and 3 months
|
|
Gastrointestinal disorders
Toothache
|
20.0%
1/5 • Number of events 1 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
5.4%
2/37 • Number of events 2 • 5 yrs and 3 months
|
|
Renal and urinary disorders
Urinary urgency/
|
40.0%
2/5 • Number of events 3 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 1 • 5 yrs and 3 months
|
10.8%
4/37 • Number of events 6 • 5 yrs and 3 months
|
|
Infections and infestations
Urinary tract infection
|
20.0%
1/5 • Number of events 1 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
5.4%
2/37 • Number of events 5 • 5 yrs and 3 months
|
|
Vascular disorders
Raynaud's
|
20.0%
1/5 • Number of events 1 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
0.00%
0/37 • 5 yrs and 3 months
|
|
General disorders
Voice alteration
|
20.0%
1/5 • Number of events 1 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 1 • 5 yrs and 3 months
|
29.7%
11/37 • Number of events 11 • 5 yrs and 3 months
|
|
Eye disorders
Watering eyes
|
20.0%
1/5 • Number of events 1 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
0.00%
0/37 • 5 yrs and 3 months
|
|
Metabolism and nutrition disorders
Weight loss
|
60.0%
3/5 • Number of events 3 • 5 yrs and 3 months
|
100.0%
3/3 • Number of events 4 • 5 yrs and 3 months
|
67.6%
25/37 • Number of events 38 • 5 yrs and 3 months
|
|
Gastrointestinal disorders
Vomitting
|
20.0%
1/5 • Number of events 1 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 1 • 5 yrs and 3 months
|
43.2%
16/37 • Number of events 35 • 5 yrs and 3 months
|
|
Hepatobiliary disorders
Aspartate aminotransferase increased
|
0.00%
0/5 • 5 yrs and 3 months
|
66.7%
2/3 • Number of events 6 • 5 yrs and 3 months
|
48.6%
18/37 • Number of events 26 • 5 yrs and 3 months
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/5 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 1 • 5 yrs and 3 months
|
0.00%
0/37 • 5 yrs and 3 months
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/5 • 5 yrs and 3 months
|
100.0%
3/3 • Number of events 4 • 5 yrs and 3 months
|
45.9%
17/37 • Number of events 32 • 5 yrs and 3 months
|
|
Immune system disorders
Allergic Reaction
|
0.00%
0/5 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 1 • 5 yrs and 3 months
|
2.7%
1/37 • Number of events 2 • 5 yrs and 3 months
|
|
Blood and lymphatic system disorders
Polycythemia
|
0.00%
0/5 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 2 • 5 yrs and 3 months
|
0.00%
0/37 • 5 yrs and 3 months
|
|
Blood and lymphatic system disorders
Elevated lactate dehydrogenase
|
0.00%
0/5 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 1 • 5 yrs and 3 months
|
0.00%
0/37 • 5 yrs and 3 months
|
|
Eye disorders
Blurred vision
|
0.00%
0/5 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 1 • 5 yrs and 3 months
|
10.8%
4/37 • Number of events 4 • 5 yrs and 3 months
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/5 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 2 • 5 yrs and 3 months
|
24.3%
9/37 • Number of events 12 • 5 yrs and 3 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • 5 yrs and 3 months
|
66.7%
2/3 • Number of events 2 • 5 yrs and 3 months
|
40.5%
15/37 • Number of events 20 • 5 yrs and 3 months
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/5 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 1 • 5 yrs and 3 months
|
21.6%
8/37 • Number of events 9 • 5 yrs and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/5 • 5 yrs and 3 months
|
66.7%
2/3 • Number of events 3 • 5 yrs and 3 months
|
37.8%
14/37 • Number of events 18 • 5 yrs and 3 months
|
|
Skin and subcutaneous tissue disorders
Perichondritis
|
0.00%
0/5 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 2 • 5 yrs and 3 months
|
0.00%
0/37 • 5 yrs and 3 months
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/5 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 1 • 5 yrs and 3 months
|
0.00%
0/37 • 5 yrs and 3 months
|
|
General disorders
Edema face
|
0.00%
0/5 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 1 • 5 yrs and 3 months
|
10.8%
4/37 • Number of events 4 • 5 yrs and 3 months
|
|
General disorders
Diabetes mellitus Type II
|
0.00%
0/5 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 1 • 5 yrs and 3 months
|
0.00%
0/37 • 5 yrs and 3 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/5 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 1 • 5 yrs and 3 months
|
2.7%
1/37 • Number of events 1 • 5 yrs and 3 months
|
|
General disorders
Flank pain
|
0.00%
0/5 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 1 • 5 yrs and 3 months
|
5.4%
2/37 • Number of events 2 • 5 yrs and 3 months
|
|
General disorders
Gait disturbance
|
0.00%
0/5 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 1 • 5 yrs and 3 months
|
8.1%
3/37 • Number of events 5 • 5 yrs and 3 months
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • 5 yrs and 3 months
|
66.7%
2/3 • Number of events 2 • 5 yrs and 3 months
|
24.3%
9/37 • Number of events 14 • 5 yrs and 3 months
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/5 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 2 • 5 yrs and 3 months
|
37.8%
14/37 • Number of events 21 • 5 yrs and 3 months
|
|
Infections and infestations
Strep Throat
|
0.00%
0/5 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 1 • 5 yrs and 3 months
|
0.00%
0/37 • 5 yrs and 3 months
|
|
Psychiatric disorders
Irritability
|
0.00%
0/5 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 2 • 5 yrs and 3 months
|
2.7%
1/37 • Number of events 1 • 5 yrs and 3 months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/5 • 5 yrs and 3 months
|
66.7%
2/3 • Number of events 4 • 5 yrs and 3 months
|
16.2%
6/37 • Number of events 6 • 5 yrs and 3 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/5 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 1 • 5 yrs and 3 months
|
0.00%
0/37 • 5 yrs and 3 months
|
|
Gastrointestinal disorders
Oral dysesthesia
|
0.00%
0/5 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 1 • 5 yrs and 3 months
|
13.5%
5/37 • Number of events 5 • 5 yrs and 3 months
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/5 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 2 • 5 yrs and 3 months
|
0.00%
0/37 • 5 yrs and 3 months
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/5 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 1 • 5 yrs and 3 months
|
37.8%
14/37 • Number of events 17 • 5 yrs and 3 months
|
|
Skin and subcutaneous tissue disorders
Hair depigmentation
|
0.00%
0/5 • 5 yrs and 3 months
|
66.7%
2/3 • Number of events 2 • 5 yrs and 3 months
|
27.0%
10/37 • Number of events 10 • 5 yrs and 3 months
|
|
Skin and subcutaneous tissue disorders
tinea corporis - umbilicus
|
0.00%
0/5 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 1 • 5 yrs and 3 months
|
0.00%
0/37 • 5 yrs and 3 months
|
|
Skin and subcutaneous tissue disorders
Rectal irritation
|
0.00%
0/5 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 1 • 5 yrs and 3 months
|
0.00%
0/37 • 5 yrs and 3 months
|
|
Skin and subcutaneous tissue disorders
Mouth Sensitivity
|
0.00%
0/5 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 1 • 5 yrs and 3 months
|
18.9%
7/37 • Number of events 7 • 5 yrs and 3 months
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/5 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 1 • 5 yrs and 3 months
|
2.7%
1/37 • Number of events 1 • 5 yrs and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/5 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 1 • 5 yrs and 3 months
|
16.2%
6/37 • Number of events 7 • 5 yrs and 3 months
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/5 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 1 • 5 yrs and 3 months
|
8.1%
3/37 • Number of events 3 • 5 yrs and 3 months
|
|
Nervous system disorders
Tremor
|
0.00%
0/5 • 5 yrs and 3 months
|
33.3%
1/3 • Number of events 1 • 5 yrs and 3 months
|
0.00%
0/37 • 5 yrs and 3 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
16.2%
6/37 • Number of events 8 • 5 yrs and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
5.4%
2/37 • Number of events 2 • 5 yrs and 3 months
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
16.2%
6/37 • Number of events 6 • 5 yrs and 3 months
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
5.4%
2/37 • Number of events 6 • 5 yrs and 3 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
5.4%
2/37 • Number of events 2 • 5 yrs and 3 months
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
27.0%
10/37 • Number of events 14 • 5 yrs and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
27.0%
10/37 • Number of events 12 • 5 yrs and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
5.4%
2/37 • Number of events 2 • 5 yrs and 3 months
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
21.6%
8/37 • Number of events 9 • 5 yrs and 3 months
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
13.5%
5/37 • Number of events 5 • 5 yrs and 3 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
29.7%
11/37 • Number of events 13 • 5 yrs and 3 months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
5.4%
2/37 • Number of events 2 • 5 yrs and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
27.0%
10/37 • Number of events 12 • 5 yrs and 3 months
|
|
Metabolism and nutrition disorders
hyperglycemia
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
8.1%
3/37 • Number of events 4 • 5 yrs and 3 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
10.8%
4/37 • Number of events 13 • 5 yrs and 3 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
24.3%
9/37 • Number of events 15 • 5 yrs and 3 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
13.5%
5/37 • Number of events 8 • 5 yrs and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
5.4%
2/37 • Number of events 2 • 5 yrs and 3 months
|
|
Cardiac disorders
Hypotension
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
10.8%
4/37 • Number of events 4 • 5 yrs and 3 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
27.0%
10/37 • Number of events 11 • 5 yrs and 3 months
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
24.3%
9/37 • Number of events 18 • 5 yrs and 3 months
|
|
General disorders
Pain (general)
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
59.5%
22/37 • Number of events 52 • 5 yrs and 3 months
|
|
Cardiac disorders
Palpitations
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
5.4%
2/37 • Number of events 2 • 5 yrs and 3 months
|
|
Investigations
Platelet count decreased
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
27.0%
10/37 • Number of events 17 • 5 yrs and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
5.4%
2/37 • Number of events 2 • 5 yrs and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
5.4%
2/37 • Number of events 2 • 5 yrs and 3 months
|
|
Infections and infestations
Tooth Infection
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
8.1%
3/37 • Number of events 5 • 5 yrs and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
13.5%
5/37 • Number of events 6 • 5 yrs and 3 months
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
8.1%
3/37 • Number of events 3 • 5 yrs and 3 months
|
|
Investigations
White blood cell decreased
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
5.4%
2/37 • Number of events 3 • 5 yrs and 3 months
|
|
Renal and urinary disorders
Abnormal urinalysis
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
5.4%
2/37 • Number of events 2 • 5 yrs and 3 months
|
|
General disorders
Activity Change
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
8.1%
3/37 • Number of events 5 • 5 yrs and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Blood Tinged Sputum
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
5.4%
2/37 • Number of events 2 • 5 yrs and 3 months
|
|
General disorders
body aches
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
5.4%
2/37 • Number of events 2 • 5 yrs and 3 months
|
|
Skin and subcutaneous tissue disorders
Callus on feet
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
10.8%
4/37 • Number of events 4 • 5 yrs and 3 months
|
|
Cardiac disorders
Chest pain
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
5.4%
2/37 • Number of events 2 • 5 yrs and 3 months
|
|
General disorders
Cold Intolerance
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
13.5%
5/37 • Number of events 5 • 5 yrs and 3 months
|
|
Gastrointestinal disorders
colitis
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
5.4%
2/37 • Number of events 2 • 5 yrs and 3 months
|
|
General disorders
Concentration Impairment
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
10.8%
4/37 • Number of events 4 • 5 yrs and 3 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
16.2%
6/37 • Number of events 6 • 5 yrs and 3 months
|
|
Gastrointestinal disorders
Dental problems
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
13.5%
5/37 • Number of events 6 • 5 yrs and 3 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
5.4%
2/37 • Number of events 2 • 5 yrs and 3 months
|
|
Skin and subcutaneous tissue disorders
Diaphoresis
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
10.8%
4/37 • Number of events 5 • 5 yrs and 3 months
|
|
Gastrointestinal disorders
Duodenal Hemorrhage
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
5.4%
2/37 • Number of events 2 • 5 yrs and 3 months
|
|
Endocrine disorders
Elevated TSH
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
8.1%
3/37 • Number of events 3 • 5 yrs and 3 months
|
|
Infections and infestations
Enterocolitis
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
5.4%
2/37 • Number of events 2 • 5 yrs and 3 months
|
|
Skin and subcutaneous tissue disorders
erythema
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
10.8%
4/37 • Number of events 4 • 5 yrs and 3 months
|
|
General disorders
Finger Cramping
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
8.1%
3/37 • Number of events 3 • 5 yrs and 3 months
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
8.1%
3/37 • Number of events 4 • 5 yrs and 3 months
|
|
Infections and infestations
Flu like symptoms
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
8.1%
3/37 • Number of events 3 • 5 yrs and 3 months
|
|
Infections and infestations
Viral hepatitis
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
5.4%
2/37 • Number of events 3 • 5 yrs and 3 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
5.4%
2/37 • Number of events 3 • 5 yrs and 3 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
5.4%
2/37 • Number of events 2 • 5 yrs and 3 months
|
|
General disorders
Malaise
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
8.1%
3/37 • Number of events 3 • 5 yrs and 3 months
|
|
Psychiatric disorders
Dysphoric Mood
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
10.8%
4/37 • Number of events 4 • 5 yrs and 3 months
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
5.4%
2/37 • Number of events 2 • 5 yrs and 3 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
5.4%
2/37 • Number of events 3 • 5 yrs and 3 months
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
8.1%
3/37 • Number of events 13 • 5 yrs and 3 months
|
|
Eye disorders
Visual disturbances
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
8.1%
3/37 • Number of events 3 • 5 yrs and 3 months
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
5.4%
2/37 • Number of events 4 • 5 yrs and 3 months
|
|
Infections and infestations
Sinusitis
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
5.4%
2/37 • Number of events 2 • 5 yrs and 3 months
|
|
General disorders
Neck stiffness
|
0.00%
0/5 • 5 yrs and 3 months
|
0.00%
0/3 • 5 yrs and 3 months
|
5.4%
2/37 • Number of events 2 • 5 yrs and 3 months
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place