Trial Outcomes & Findings for Study of Lenvatinib in Combination With Everolimus in Participants With Unresectable Advanced or Metastatic Renal Cell Carcinoma (RCC) (NCT NCT02454478)
NCT ID: NCT02454478
Last Updated: 2019-03-19
Results Overview
DLT was defined as toxicity related to the combination therapy and was graded according to Common Terminology Criteria for Adverse Events version 4.03 (CTCAE v4.03).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
7 participants
Primary outcome timeframe
From first dose of study drug up to Cycle 1 Day 28 (Cycle length=28 days)
Results posted on
2019-03-19
Participant Flow
Participants took part in the study at 3 sites in Japan from 01 July 2015 to 29 May 2017.
A total of 9 participants were screened, of which 7 were enrolled and treated in the study.
Participant milestones
| Measure |
Lenvatinib 18 mg + Everolimus 5 mg
Participants received lenvatinib 18 milligram (mg) capsules along with everolimus 5 mg tablets, orally, once daily in 28-days treatment cycles up to disease progression, development of unacceptable toxicity, participant's request to discontinue, withdrawal of consent, or study termination by sponsor (up to 23 cycles).
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Lenvatinib 18 mg + Everolimus 5 mg
Participants received lenvatinib 18 milligram (mg) capsules along with everolimus 5 mg tablets, orally, once daily in 28-days treatment cycles up to disease progression, development of unacceptable toxicity, participant's request to discontinue, withdrawal of consent, or study termination by sponsor (up to 23 cycles).
|
|---|---|
|
Overall Study
Incomplete DLT Evaluation
|
1
|
Baseline Characteristics
Study of Lenvatinib in Combination With Everolimus in Participants With Unresectable Advanced or Metastatic Renal Cell Carcinoma (RCC)
Baseline characteristics by cohort
| Measure |
Lenvatinib 18 mg + Everolimus 5 mg
n=7 Participants
Participants received lenvatinib 18 mg capsules along with everolimus 5 mg tablets, orally, once daily in 28-days treatment cycles up to disease progression, development of unacceptable toxicity, participant's request to discontinue, withdrawal of consent, or study termination by sponsor (up to 23 cycles).
|
|---|---|
|
Age, Continuous
|
65.7 years
STANDARD_DEVIATION 6.29 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug up to Cycle 1 Day 28 (Cycle length=28 days)Population: The DLT analysis set was the group of participants who had completed treatment Cycle 1 without major protocol deviation with a treatment compliance of at least 75 percent (%) and had been assessed for DLT, and participants who had experienced DLT during Cycle 1.
DLT was defined as toxicity related to the combination therapy and was graded according to Common Terminology Criteria for Adverse Events version 4.03 (CTCAE v4.03).
Outcome measures
| Measure |
Lenvatinib 18 mg + Everolimus 5 mg
n=6 Participants
Participants received lenvatinib 18 mg capsules along with everolimus 5 mg tablets, orally, once daily in 28-days treatment cycles up to disease progression, development of unacceptable toxicity, participant's request to discontinue, withdrawal of consent, or study termination by sponsor (up to 23 cycles).
|
|---|---|
|
Number of Participants Who Experienced Any Dose Limiting Toxicity (DLT)
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)Population: The safety analysis set was the group of participants who received at least 1 dose of lenvatinib.
Outcome measures
| Measure |
Lenvatinib 18 mg + Everolimus 5 mg
n=7 Participants
Participants received lenvatinib 18 mg capsules along with everolimus 5 mg tablets, orally, once daily in 28-days treatment cycles up to disease progression, development of unacceptable toxicity, participant's request to discontinue, withdrawal of consent, or study termination by sponsor (up to 23 cycles).
|
|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAE
|
7 participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAE
|
3 participants
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 predose and at 1, 2, 4 ,8, and 24 hours postdose (Cycle length=28 days)Population: The pharmacokinetic (PK) analysis was group of participants who received at least 1 dose of lenvatinib and had sufficient data from which at least one PK parameter could be calculated.
Outcome measures
| Measure |
Lenvatinib 18 mg + Everolimus 5 mg
n=7 Participants
Participants received lenvatinib 18 mg capsules along with everolimus 5 mg tablets, orally, once daily in 28-days treatment cycles up to disease progression, development of unacceptable toxicity, participant's request to discontinue, withdrawal of consent, or study termination by sponsor (up to 23 cycles).
|
|---|---|
|
Cmax: Maximum Observed Plasma Concentration for Levatinib and Everolimus
Lenvatinib: Cycle 1 Day 1
|
289 nanogram per milliliter (ng/mL)
Standard Deviation 136
|
|
Cmax: Maximum Observed Plasma Concentration for Levatinib and Everolimus
Everolimus: Cycle 1 Day 1
|
39.1 nanogram per milliliter (ng/mL)
Standard Deviation 18.7
|
SECONDARY outcome
Timeframe: Cycle 1 Day 15 predose and at 1, 2, 4 ,8, and 24 hours postdose (Cycle length=28 days)Population: The PK analysis was group of participants who received at least 1 dose of lenvatinib and had sufficient data from which at least one PK parameter could be calculated. The PK analysis set where data at specified time points was available.
Outcome measures
| Measure |
Lenvatinib 18 mg + Everolimus 5 mg
n=7 Participants
Participants received lenvatinib 18 mg capsules along with everolimus 5 mg tablets, orally, once daily in 28-days treatment cycles up to disease progression, development of unacceptable toxicity, participant's request to discontinue, withdrawal of consent, or study termination by sponsor (up to 23 cycles).
|
|---|---|
|
Css,Max: Maximum Observed Plasma Concentration at Steady State for Levatinib and Everolimus
Lenvatinib: Cycle 1 Day 15
|
257 ng/mL
Standard Deviation 112
|
|
Css,Max: Maximum Observed Plasma Concentration at Steady State for Levatinib and Everolimus
Everolimus: Cycle 1 Day 15
|
41.5 ng/mL
Standard Deviation 19.3
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 predose and at 1, 2, 4 ,8, and 24 hours postdose (Cycle length=28 days)Population: The PK analysis was group of participants who received at least 1 dose of lenvatinib and had sufficient data from which at least one PK parameter could be calculated.
Outcome measures
| Measure |
Lenvatinib 18 mg + Everolimus 5 mg
n=7 Participants
Participants received lenvatinib 18 mg capsules along with everolimus 5 mg tablets, orally, once daily in 28-days treatment cycles up to disease progression, development of unacceptable toxicity, participant's request to discontinue, withdrawal of consent, or study termination by sponsor (up to 23 cycles).
|
|---|---|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Levatinib and Everolimus
Lenvatinib: Cycle 1 Day 1
|
3.87 hour
Interval 0.95 to 3.87
|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Levatinib and Everolimus
Everolimus: Cycle 1 Day 1
|
0.92 hour
Interval 0.82 to 1.1
|
SECONDARY outcome
Timeframe: Cycle 1 Day 15 predose and at 1, 2, 4 ,8, and 24 hours postdose (Cycle length=28 days)Population: The PK analysis was group of participants who received at least 1 dose of lenvatinib and had sufficient data from which at least one PK parameter could be calculated. The PK analysis set where data at specified time points was available.
Outcome measures
| Measure |
Lenvatinib 18 mg + Everolimus 5 mg
n=7 Participants
Participants received lenvatinib 18 mg capsules along with everolimus 5 mg tablets, orally, once daily in 28-days treatment cycles up to disease progression, development of unacceptable toxicity, participant's request to discontinue, withdrawal of consent, or study termination by sponsor (up to 23 cycles).
|
|---|---|
|
Tss,Max: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for Levatinib and Everolimus
Lenvatinib: Cycle 1 Day 15
|
3.77 hour
Interval 1.88 to 4.08
|
|
Tss,Max: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for Levatinib and Everolimus
Everolimus: Cycle 1 Day 15
|
0.97 hour
Interval 0.83 to 3.97
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 and Cycle 1 Day 15 predose and at 1, 2, 4 ,8, and 24 hours postdose (Cycle length=28 days)Population: The PK analysis set was group of participants who received at least 1 dose of lenvatinib and had sufficient data from which at least one PK parameter could be calculated. The PK analysis set where data at specified time points was available.
Outcome measures
| Measure |
Lenvatinib 18 mg + Everolimus 5 mg
n=7 Participants
Participants received lenvatinib 18 mg capsules along with everolimus 5 mg tablets, orally, once daily in 28-days treatment cycles up to disease progression, development of unacceptable toxicity, participant's request to discontinue, withdrawal of consent, or study termination by sponsor (up to 23 cycles).
|
|---|---|
|
AUC 0-t: Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration for Levatinib and Everolimus
Lenvatinib: Cycle 1 Day 1
|
2770 hour * nanogram per milliliter (h*ng/mL)
Standard Deviation 1090
|
|
AUC 0-t: Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration for Levatinib and Everolimus
Everolimus: Cycle 1 Day 1
|
211 hour * nanogram per milliliter (h*ng/mL)
Standard Deviation 115
|
|
AUC 0-t: Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration for Levatinib and Everolimus
Lenvatinib: Cycle 1 Day 15
|
3220 hour * nanogram per milliliter (h*ng/mL)
Standard Deviation 1080
|
|
AUC 0-t: Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration for Levatinib and Everolimus
Everolimus: Cycle 1 Day 15
|
401 hour * nanogram per milliliter (h*ng/mL)
Standard Deviation 128
|
SECONDARY outcome
Timeframe: From first dose of study drug until PD, development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent or study termination (up to approximately 23 months)Population: The efficacy analysis set was the group of participants who received at least 1 dose of lenvatinib.
BOR included complete response (CR), partial response (PR), stable disease (SD), and PD (progressive disease). BOR was assessed using Response Evaluation Criteria in Solid Tumor (RECIST) 1.1
Outcome measures
| Measure |
Lenvatinib 18 mg + Everolimus 5 mg
n=7 Participants
Participants received lenvatinib 18 mg capsules along with everolimus 5 mg tablets, orally, once daily in 28-days treatment cycles up to disease progression, development of unacceptable toxicity, participant's request to discontinue, withdrawal of consent, or study termination by sponsor (up to 23 cycles).
|
|---|---|
|
Number of Participants With Best Overall Response (BOR)
CR
|
0 participants
|
|
Number of Participants With Best Overall Response (BOR)
PR
|
5 participants
|
|
Number of Participants With Best Overall Response (BOR)
SD
|
1 participants
|
|
Number of Participants With Best Overall Response (BOR)
PD
|
1 participants
|
SECONDARY outcome
Timeframe: From first dose of study drug until PD, development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent or study termination (up to approximately 23 months)Population: The efficacy analysis set was the group of participants who received at least 1 dose of lenvatinib.
ORR was defined as the percentage of participants who achieved BOR of CR or PR. ORR was assessed using RECIST 1.1.
Outcome measures
| Measure |
Lenvatinib 18 mg + Everolimus 5 mg
n=7 Participants
Participants received lenvatinib 18 mg capsules along with everolimus 5 mg tablets, orally, once daily in 28-days treatment cycles up to disease progression, development of unacceptable toxicity, participant's request to discontinue, withdrawal of consent, or study termination by sponsor (up to 23 cycles).
|
|---|---|
|
Objective Response Rate (ORR)
|
71.4 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose of study drug until PD, development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent or study termination (up to approximately 23 months)Population: The efficacy analysis set was the group of participants who received at least 1 dose of lenvatinib.
DCR was defined as the percentage of participants who achieved BOR of CR, PR, or SD. DCR was assessed based on RECIST 1.1.
Outcome measures
| Measure |
Lenvatinib 18 mg + Everolimus 5 mg
n=7 Participants
Participants received lenvatinib 18 mg capsules along with everolimus 5 mg tablets, orally, once daily in 28-days treatment cycles up to disease progression, development of unacceptable toxicity, participant's request to discontinue, withdrawal of consent, or study termination by sponsor (up to 23 cycles).
|
|---|---|
|
Disease Control Rate (DCR)
|
85.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to first tumor assessment at which diameter of target lesions were available (up to approximately 23 months)Population: The efficacy analysis set was the group of participants who received at least 1 dose of lenvatinib.
Outcome measures
| Measure |
Lenvatinib 18 mg + Everolimus 5 mg
n=7 Participants
Participants received lenvatinib 18 mg capsules along with everolimus 5 mg tablets, orally, once daily in 28-days treatment cycles up to disease progression, development of unacceptable toxicity, participant's request to discontinue, withdrawal of consent, or study termination by sponsor (up to 23 cycles).
|
|---|---|
|
Number of Participants With the Minimum Percent Change From Baseline in the Sum of Diameters of Target Lesions
Less than or equal to (<=) -30%
|
5 participants
|
|
Number of Participants With the Minimum Percent Change From Baseline in the Sum of Diameters of Target Lesions
Greater than (>) -30% to less than (<) 20%
|
1 participants
|
|
Number of Participants With the Minimum Percent Change From Baseline in the Sum of Diameters of Target Lesions
Greater than or equal to (>=) 20%
|
1 participants
|
Adverse Events
Lenvatinib 18 mg + Everolimus 5 mg
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lenvatinib 18 mg + Everolimus 5 mg
n=7 participants at risk
Participants received lenvatinib 18 mg capsules along with everolimus 5 mg tablets, orally, once daily in 28-days treatment cycles up to disease progression, development of unacceptable toxicity, participant's request to discontinue withdrawal of consent, or study termination by sponsor (up to 23 cycles).
|
|---|---|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Metabolism and nutrition disorders
Dehydration
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
Other adverse events
| Measure |
Lenvatinib 18 mg + Everolimus 5 mg
n=7 participants at risk
Participants received lenvatinib 18 mg capsules along with everolimus 5 mg tablets, orally, once daily in 28-days treatment cycles up to disease progression, development of unacceptable toxicity, participant's request to discontinue withdrawal of consent, or study termination by sponsor (up to 23 cycles).
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
100.0%
7/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Blood and lymphatic system disorders
Leukopenia
|
71.4%
5/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Blood and lymphatic system disorders
Lymphopenia
|
71.4%
5/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Blood and lymphatic system disorders
Neutropenia
|
71.4%
5/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Blood and lymphatic system disorders
Anaemia
|
57.1%
4/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Blood and lymphatic system disorders
Leukocytosis
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
General disorders
Fatigue
|
71.4%
5/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
General disorders
Oedema peripheral
|
71.4%
5/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
General disorders
Pyrexia
|
57.1%
4/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Investigations
Blood cholesterol increased
|
71.4%
5/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Investigations
Weight decreased
|
71.4%
5/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Investigations
Alanine aminotransferase increased
|
42.9%
3/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Investigations
Aspartate aminotransferase increased
|
42.9%
3/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Investigations
Lipase increased
|
28.6%
2/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Investigations
Amylase increased
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Investigations
Blood alkaline phosphatase increased
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Investigations
Blood bilirubin increased
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Investigations
Blood creatine phosphokinase increased
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Investigations
Blood creatinine increased
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Investigations
Blood lactate dehydrogenase increased
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Investigations
Ejection fraction decreased
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
85.7%
6/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
85.7%
6/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
42.9%
3/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
42.9%
3/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
28.6%
2/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
28.6%
2/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
28.6%
2/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
28.6%
2/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Metabolism and nutrition disorders
Dehydration
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
85.7%
6/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
28.6%
2/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
28.6%
2/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
71.4%
5/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Gastrointestinal disorders
Nausea
|
57.1%
4/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Gastrointestinal disorders
Stomatitis
|
42.9%
3/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
28.6%
2/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Gastrointestinal disorders
Constipation
|
28.6%
2/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Gastrointestinal disorders
Vomiting
|
28.6%
2/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Gastrointestinal disorders
Dental caries
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Gastrointestinal disorders
Haematochezia
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Gastrointestinal disorders
Haemorrhoids
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Gastrointestinal disorders
Traumatic occlusion
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
57.1%
4/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
57.1%
4/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
42.9%
3/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
28.6%
2/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Renal and urinary disorders
Proteinuria
|
71.4%
5/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Renal and urinary disorders
Haematuria
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Renal and urinary disorders
Urinary retention
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Endocrine disorders
Hypothyroidism
|
57.1%
4/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Infections and infestations
Periodontitis
|
28.6%
2/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Infections and infestations
Gingivitis
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Infections and infestations
Pneumonia
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Infections and infestations
Sinusitis
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Infections and infestations
Tooth infection
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Infections and infestations
Urinary tract infection
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Infections and infestations
Viral upper respiratory tract infection
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Infections and infestations
Wound infection
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Nervous system disorders
Dysgeusia
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Vascular disorders
Hypertension
|
42.9%
3/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Eye disorders
Eyelid oedema
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Injury, poisoning and procedural complications
Wound
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
|
Psychiatric disorders
Insomnia
|
14.3%
1/7 • Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place