Trial Outcomes & Findings for Nivolumab (BMS-936558; MDX-1106) in Combination With Sunitinib, Pazopanib, or Ipilimumab in Subjects With Metastatic Renal Cell Carcinoma (RCC) (CheckMate 016) (NCT NCT01472081)
NCT ID: NCT01472081
Last Updated: 2021-12-02
Results Overview
Safety assessments by treatment arm and dose level were based on incidence of AEs, and the incidence of serious adverse events (SAEs). AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
194 participants
Primary outcome timeframe
From date of first dose to date of last dose plus 100 days (assessed up to March 2016, approximately 49 months)
Results posted on
2021-12-02
Participant Flow
194 participants were enrolled; 153 were treated. Participants were enrolled but not treated due to the following reasons: withdrawal of consent (n=5), no longer met study criteria (n=32), administrative reason by sponsor (n=1), or other reasons (n=3)
Participant milestones
| Measure |
Arm S: SUN + NIV2
Nivolumab 2 mg/kg administered on Day 1 and 22 of each 6 week (42 day) cycle as a 1-hour IV infusion followed 60 minutes later with Sunitinib 50 mg orally on Day 1 - 28 of each 42 day cycle until Progressive Disease (PD), toxicity or discontinuation for other reasons.
|
Arm S: SUN + NIV5
Nivolumab 5 mg/kg administered on Day 1 and 22 of each 6 week (42 day) cycle as a 1-hour IV infusion followed 60 minutes later with Sunitinib 50 mg orally on Day 1 - 28 of each 42 day cycle until Progressive Disease (PD), toxicity or discontinuation for other reasons.
|
Arm P: PAZ + NIV2
Nivolumab 2 mg/kg administered on Day 1 and 22 of each 6 week (42 day) cycle as a 1-hour IV infusion followed 60 minutes later with Pazopanib 800 mg orally on Day 1 - 42 of each 42 day cycle until Progressive Disease (PD), toxicity or discontinuation for other reasons.
|
Arm I-1: IPI1 + NIV3
Induction: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion followed by Ipilimumab 1 mg/kg administered IV infusion over 90 minutes every 3 weeks for 4 doses.
Maintenance: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion every 2 weeks, starting 3 weeks after the 4th dose of induction therapy or after Day 113 if the 4th dose of induction therapy had not been administered due to treatment delays.
|
Arm I-3: IPI3 + NIV1
Induction: Nivolumab 1 mg/kg was administered as a 1-hour IV infusion followed by Ipilimumab 3 mg/kg administered IV infusion over 90 minutes every 3 weeks for 4 doses.
Maintenance: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion every 2 weeks, starting 3 weeks after the 4th dose of induction therapy or after Day 113 if the 4th dose of induction therapy had not been administered due to treatment delays.
|
Arm IN-3: IPI3 + NIV3
Induction: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion followed by Ipilimumab 3 mg/kg administered IV infusion over 90 minutes every 3 weeks for 4 doses.
Maintenance: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion every 2 weeks, starting 3 weeks after the 4th dose of induction therapy or after Day 113 if the 4th dose of induction therapy had not been administered due to treatment delays.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
26
|
20
|
47
|
47
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
26
|
20
|
46
|
47
|
6
|
Reasons for withdrawal
| Measure |
Arm S: SUN + NIV2
Nivolumab 2 mg/kg administered on Day 1 and 22 of each 6 week (42 day) cycle as a 1-hour IV infusion followed 60 minutes later with Sunitinib 50 mg orally on Day 1 - 28 of each 42 day cycle until Progressive Disease (PD), toxicity or discontinuation for other reasons.
|
Arm S: SUN + NIV5
Nivolumab 5 mg/kg administered on Day 1 and 22 of each 6 week (42 day) cycle as a 1-hour IV infusion followed 60 minutes later with Sunitinib 50 mg orally on Day 1 - 28 of each 42 day cycle until Progressive Disease (PD), toxicity or discontinuation for other reasons.
|
Arm P: PAZ + NIV2
Nivolumab 2 mg/kg administered on Day 1 and 22 of each 6 week (42 day) cycle as a 1-hour IV infusion followed 60 minutes later with Pazopanib 800 mg orally on Day 1 - 42 of each 42 day cycle until Progressive Disease (PD), toxicity or discontinuation for other reasons.
|
Arm I-1: IPI1 + NIV3
Induction: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion followed by Ipilimumab 1 mg/kg administered IV infusion over 90 minutes every 3 weeks for 4 doses.
Maintenance: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion every 2 weeks, starting 3 weeks after the 4th dose of induction therapy or after Day 113 if the 4th dose of induction therapy had not been administered due to treatment delays.
|
Arm I-3: IPI3 + NIV1
Induction: Nivolumab 1 mg/kg was administered as a 1-hour IV infusion followed by Ipilimumab 3 mg/kg administered IV infusion over 90 minutes every 3 weeks for 4 doses.
Maintenance: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion every 2 weeks, starting 3 weeks after the 4th dose of induction therapy or after Day 113 if the 4th dose of induction therapy had not been administered due to treatment delays.
|
Arm IN-3: IPI3 + NIV3
Induction: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion followed by Ipilimumab 3 mg/kg administered IV infusion over 90 minutes every 3 weeks for 4 doses.
Maintenance: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion every 2 weeks, starting 3 weeks after the 4th dose of induction therapy or after Day 113 if the 4th dose of induction therapy had not been administered due to treatment delays.
|
|---|---|---|---|---|---|---|
|
Overall Study
Continuing treatment at time of analysis
|
1
|
4
|
1
|
8
|
9
|
0
|
|
Overall Study
Disease Progression
|
4
|
10
|
12
|
31
|
22
|
3
|
|
Overall Study
Study drug toxicity
|
2
|
9
|
4
|
6
|
13
|
2
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Adverse Event unrelated to study drug
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Poor/non-compliance
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Overall Study
No longer meets study criteria
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Subject request to discontinue treatment
|
0
|
3
|
1
|
1
|
0
|
0
|
Baseline Characteristics
Nivolumab (BMS-936558; MDX-1106) in Combination With Sunitinib, Pazopanib, or Ipilimumab in Subjects With Metastatic Renal Cell Carcinoma (RCC) (CheckMate 016)
Baseline characteristics by cohort
| Measure |
Arm S: SUN + NIV2
n=7 Participants
Nivolumab 2 mg/kg administered on Day 1 and 22 of each 6 week (42 day) cycle as a 1-hour IV infusion followed 60 minutes later with Sunitinib 50 mg orally on Day 1 - 28 of each 42 day cycle until Progressive Disease (PD), toxicity or discontinuation for other reasons.
|
Arm S: SUN + NIV5
n=26 Participants
Nivolumab 5 mg/kg administered on Day 1 and 22 of each 6 week (42 day) cycle as a 1-hour IV infusion followed 60 minutes later with Sunitinib 50 mg orally on Day 1 - 28 of each 42 day cycle until Progressive Disease (PD), toxicity or discontinuation for other reasons.
|
Arm P: PAZ + NIV2
n=20 Participants
Nivolumab 2 mg/kg administered on Day 1 and 22 of each 6 week (42 day) cycle as a 1-hour IV infusion followed 60 minutes later with Pazopanib 800 mg orally on Day 1 - 42 of each 42 day cycle until Progressive Disease (PD), toxicity or discontinuation for other reasons.
|
Arm I-1: IPI1 + NIV3
n=47 Participants
Induction: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion followed by Ipilimumab 1 mg/kg administered IV infusion over 90 minutes every 3 weeks for 4 doses.
Maintenance: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion every 2 weeks, starting 3 weeks after the 4th dose of induction therapy or after Day 113 if the 4th dose of induction therapy had not been administered due to treatment delays.
|
Arm I-3: IPI3 + NIV1
n=47 Participants
Induction: Nivolumab 1 mg/kg was administered as a 1-hour IV infusion followed by Ipilimumab 3 mg/kg administered IV infusion over 90 minutes every 3 weeks for 4 doses.
Maintenance: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion every 2 weeks, starting 3 weeks after the 4th dose of induction therapy or after Day 113 if the 4th dose of induction therapy had not been administered due to treatment delays.
|
Arm IN-3: IPI3 + NIV3
n=6 Participants
Induction: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion followed by Ipilimumab 3 mg/kg administered IV infusion over 90 minutes every 3 weeks for 4 doses.
Maintenance: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion every 2 weeks, starting 3 weeks after the 4th dose of induction therapy or after Day 113 if the 4th dose of induction therapy had not been administered due to treatment delays.
|
Total
n=153 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
56.9 years
STANDARD_DEVIATION 11.36 • n=5 Participants
|
58.3 years
STANDARD_DEVIATION 8.62 • n=7 Participants
|
56.3 years
STANDARD_DEVIATION 8.52 • n=5 Participants
|
53.0 years
STANDARD_DEVIATION 8.97 • n=4 Participants
|
55.6 years
STANDARD_DEVIATION 11.58 • n=21 Participants
|
54.8 years
STANDARD_DEVIATION 2.71 • n=8 Participants
|
55.4 years
STANDARD_DEVIATION 9.71 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
33 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
120 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
134 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
13 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
141 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: From date of first dose to date of last dose plus 100 days (assessed up to March 2016, approximately 49 months)Population: All treated participants
Safety assessments by treatment arm and dose level were based on incidence of AEs, and the incidence of serious adverse events (SAEs). AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling.
Outcome measures
| Measure |
Arm S: SUN + NIV2
n=7 Participants
Nivolumab 2 mg/kg administered on Day 1 and 22 of each 6 week (42 day) cycle as a 1-hour IV infusion followed 60 minutes later with Sunitinib 50 mg orally on Day 1 - 28 of each 42 day cycle until Progressive Disease (PD), toxicity or discontinuation for other reasons.
|
Arm S: SUN + NIV5
n=26 Participants
Nivolumab 5 mg/kg administered on Day 1 and 22 of each 6 week (42 day) cycle as a 1-hour IV infusion followed 60 minutes later with Sunitinib 50 mg orally on Day 1 - 28 of each 42 day cycle until Progressive Disease (PD), toxicity or discontinuation for other reasons.
|
Arm P: PAZ + NIV2
n=20 Participants
Nivolumab 2 mg/kg administered on Day 1 and 22 of each 6 week (42 day) cycle as a 1-hour IV infusion followed 60 minutes later with Pazopanib 800 mg orally on Day 1 - 42 of each 42 day cycle until Progressive Disease (PD), toxicity or discontinuation for other reasons.
|
Arm I-1: IPI1 + NIV3
n=47 Participants
Induction: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion followed by Ipilimumab 1 mg/kg administered IV infusion over 90 minutes every 3 weeks for 4 doses.
Maintenance: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion every 2 weeks, starting 3 weeks after the 4th dose of induction therapy or after Day 113 if the 4th dose of induction therapy had not been administered due to treatment delays.
|
Arm I-3: IPI3 + NIV1
n=47 Participants
Induction: Nivolumab 1 mg/kg was administered as a 1-hour IV infusion followed by Ipilimumab 3 mg/kg administered IV infusion over 90 minutes every 3 weeks for 4 doses.
Maintenance: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion every 2 weeks, starting 3 weeks after the 4th dose of induction therapy or after Day 113 if the 4th dose of induction therapy had not been administered due to treatment delays.
|
Arm IN-3: IPI3 + NIV3
n=6 Participants
Induction: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion followed by Ipilimumab 3 mg/kg administered IV infusion over 90 minutes every 3 weeks for 4 doses.
Maintenance: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion every 2 weeks, starting 3 weeks after the 4th dose of induction therapy or after Day 113 if the 4th dose of induction therapy had not been administered due to treatment delays.
|
|---|---|---|---|---|---|---|
|
Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation
Drug-related AEs (any grade)
|
7 participants
|
26 participants
|
20 participants
|
43 participants
|
45 participants
|
6 participants
|
|
Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation
Drug-related SAEs (grade 3-4)
|
0 participants
|
10 participants
|
2 participants
|
9 participants
|
16 participants
|
3 participants
|
|
Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation
All-cause AEs led to discontinuation (any grade)
|
3 participants
|
10 participants
|
5 participants
|
5 participants
|
15 participants
|
2 participants
|
|
Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation
All-Causality AEs (any grade)
|
7 participants
|
26 participants
|
20 participants
|
47 participants
|
47 participants
|
6 participants
|
|
Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation
Drug-related AEs (grade 3-4)
|
5 participants
|
22 participants
|
14 participants
|
18 participants
|
29 participants
|
5 participants
|
|
Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation
All-causality SAEs (grade 3-4)
|
1 participants
|
14 participants
|
10 participants
|
20 participants
|
24 participants
|
4 participants
|
|
Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation
Drug-related SAEs (any grade)
|
2 participants
|
12 participants
|
2 participants
|
11 participants
|
16 participants
|
3 participants
|
|
Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation
All-cause AEs led to discontinuation (grade 3-4)
|
2 participants
|
9 participants
|
4 participants
|
3 participants
|
11 participants
|
0 participants
|
|
Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation
All-Causality AEs (grade 3-4)
|
6 participants
|
24 participants
|
16 participants
|
33 participants
|
34 participants
|
6 participants
|
|
Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation
All-causality SAEs (any grade)
|
3 participants
|
16 participants
|
13 participants
|
29 participants
|
30 participants
|
4 participants
|
SECONDARY outcome
Timeframe: From date of first dose to date of disease progression or subsequent anti-cancer therapy, whichever occurred first (assessed up to March 2016, approximately 49 months)Population: All treated participants
BOR was defined as the best response designation over the study as a whole, recorded between the date of first dose of study medication and the date of objectively documented progression per RECIST 1.1 criteria or the date of subsequent anti-cancer therapy, whichever occurred first. CR = Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD = At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. SD = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
Arm S: SUN + NIV2
n=7 Participants
Nivolumab 2 mg/kg administered on Day 1 and 22 of each 6 week (42 day) cycle as a 1-hour IV infusion followed 60 minutes later with Sunitinib 50 mg orally on Day 1 - 28 of each 42 day cycle until Progressive Disease (PD), toxicity or discontinuation for other reasons.
|
Arm S: SUN + NIV5
n=26 Participants
Nivolumab 5 mg/kg administered on Day 1 and 22 of each 6 week (42 day) cycle as a 1-hour IV infusion followed 60 minutes later with Sunitinib 50 mg orally on Day 1 - 28 of each 42 day cycle until Progressive Disease (PD), toxicity or discontinuation for other reasons.
|
Arm P: PAZ + NIV2
n=20 Participants
Nivolumab 2 mg/kg administered on Day 1 and 22 of each 6 week (42 day) cycle as a 1-hour IV infusion followed 60 minutes later with Pazopanib 800 mg orally on Day 1 - 42 of each 42 day cycle until Progressive Disease (PD), toxicity or discontinuation for other reasons.
|
Arm I-1: IPI1 + NIV3
n=47 Participants
Induction: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion followed by Ipilimumab 1 mg/kg administered IV infusion over 90 minutes every 3 weeks for 4 doses.
Maintenance: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion every 2 weeks, starting 3 weeks after the 4th dose of induction therapy or after Day 113 if the 4th dose of induction therapy had not been administered due to treatment delays.
|
Arm I-3: IPI3 + NIV1
n=47 Participants
Induction: Nivolumab 1 mg/kg was administered as a 1-hour IV infusion followed by Ipilimumab 3 mg/kg administered IV infusion over 90 minutes every 3 weeks for 4 doses.
Maintenance: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion every 2 weeks, starting 3 weeks after the 4th dose of induction therapy or after Day 113 if the 4th dose of induction therapy had not been administered due to treatment delays.
|
Arm IN-3: IPI3 + NIV3
n=6 Participants
Induction: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion followed by Ipilimumab 3 mg/kg administered IV infusion over 90 minutes every 3 weeks for 4 doses.
Maintenance: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion every 2 weeks, starting 3 weeks after the 4th dose of induction therapy or after Day 113 if the 4th dose of induction therapy had not been administered due to treatment delays.
|
|---|---|---|---|---|---|---|
|
Best Overall Response Rate (BOR)
Complete Response
|
1 percentage of participants
|
0 percentage of participants
|
1 percentage of participants
|
5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Best Overall Response Rate (BOR)
Partial Response
|
5 percentage of participants
|
11 percentage of participants
|
8 percentage of participants
|
14 percentage of participants
|
19 percentage of participants
|
0 percentage of participants
|
|
Best Overall Response Rate (BOR)
Stable Disease
|
1 percentage of participants
|
11 percentage of participants
|
7 percentage of participants
|
19 percentage of participants
|
17 percentage of participants
|
5 percentage of participants
|
|
Best Overall Response Rate (BOR)
Progressive Disease
|
0 percentage of participants
|
1 percentage of participants
|
4 percentage of participants
|
8 percentage of participants
|
8 percentage of participants
|
1 percentage of participants
|
|
Best Overall Response Rate (BOR)
Unable to Determine
|
0 percentage of participants
|
3 percentage of participants
|
0 percentage of participants
|
1 percentage of participants
|
3 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From date of first dose to interim analysis (Assessed up to March 2016, approximately 49 months)Population: All treated participants
ORR was defined as the proportion of participants who achieved a BOR of either complete response (CR) or partial response (PR) in the population of interest. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Arm S: SUN + NIV2
n=7 Participants
Nivolumab 2 mg/kg administered on Day 1 and 22 of each 6 week (42 day) cycle as a 1-hour IV infusion followed 60 minutes later with Sunitinib 50 mg orally on Day 1 - 28 of each 42 day cycle until Progressive Disease (PD), toxicity or discontinuation for other reasons.
|
Arm S: SUN + NIV5
n=26 Participants
Nivolumab 5 mg/kg administered on Day 1 and 22 of each 6 week (42 day) cycle as a 1-hour IV infusion followed 60 minutes later with Sunitinib 50 mg orally on Day 1 - 28 of each 42 day cycle until Progressive Disease (PD), toxicity or discontinuation for other reasons.
|
Arm P: PAZ + NIV2
n=20 Participants
Nivolumab 2 mg/kg administered on Day 1 and 22 of each 6 week (42 day) cycle as a 1-hour IV infusion followed 60 minutes later with Pazopanib 800 mg orally on Day 1 - 42 of each 42 day cycle until Progressive Disease (PD), toxicity or discontinuation for other reasons.
|
Arm I-1: IPI1 + NIV3
n=47 Participants
Induction: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion followed by Ipilimumab 1 mg/kg administered IV infusion over 90 minutes every 3 weeks for 4 doses.
Maintenance: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion every 2 weeks, starting 3 weeks after the 4th dose of induction therapy or after Day 113 if the 4th dose of induction therapy had not been administered due to treatment delays.
|
Arm I-3: IPI3 + NIV1
n=47 Participants
Induction: Nivolumab 1 mg/kg was administered as a 1-hour IV infusion followed by Ipilimumab 3 mg/kg administered IV infusion over 90 minutes every 3 weeks for 4 doses.
Maintenance: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion every 2 weeks, starting 3 weeks after the 4th dose of induction therapy or after Day 113 if the 4th dose of induction therapy had not been administered due to treatment delays.
|
Arm IN-3: IPI3 + NIV3
n=6 Participants
Induction: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion followed by Ipilimumab 3 mg/kg administered IV infusion over 90 minutes every 3 weeks for 4 doses.
Maintenance: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion every 2 weeks, starting 3 weeks after the 4th dose of induction therapy or after Day 113 if the 4th dose of induction therapy had not been administered due to treatment delays.
|
|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR)
|
85.7 percentage of participants
Interval 42.1 to 99.6
|
42.3 percentage of participants
Interval 23.4 to 63.1
|
45.0 percentage of participants
Interval 23.1 to 68.5
|
40.4 percentage of participants
Interval 26.4 to 55.7
|
40.4 percentage of participants
Interval 26.4 to 55.7
|
0 percentage of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: From date of first dose to date of disease progression or death, whichever occurred first (assessed up to March 2016, approximately 49 months)Population: All treated participants
DOR was computed for participants with BOR of CR or PR only, and defined as the time between the date of first documented objective response and the date of the first subsequent disease progression or death. Participants who remained alive and had not progressed were censored on the last tumor assessment date (prior to subsequent cancer therapy).
Outcome measures
| Measure |
Arm S: SUN + NIV2
n=7 Participants
Nivolumab 2 mg/kg administered on Day 1 and 22 of each 6 week (42 day) cycle as a 1-hour IV infusion followed 60 minutes later with Sunitinib 50 mg orally on Day 1 - 28 of each 42 day cycle until Progressive Disease (PD), toxicity or discontinuation for other reasons.
|
Arm S: SUN + NIV5
n=26 Participants
Nivolumab 5 mg/kg administered on Day 1 and 22 of each 6 week (42 day) cycle as a 1-hour IV infusion followed 60 minutes later with Sunitinib 50 mg orally on Day 1 - 28 of each 42 day cycle until Progressive Disease (PD), toxicity or discontinuation for other reasons.
|
Arm P: PAZ + NIV2
n=20 Participants
Nivolumab 2 mg/kg administered on Day 1 and 22 of each 6 week (42 day) cycle as a 1-hour IV infusion followed 60 minutes later with Pazopanib 800 mg orally on Day 1 - 42 of each 42 day cycle until Progressive Disease (PD), toxicity or discontinuation for other reasons.
|
Arm I-1: IPI1 + NIV3
n=47 Participants
Induction: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion followed by Ipilimumab 1 mg/kg administered IV infusion over 90 minutes every 3 weeks for 4 doses.
Maintenance: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion every 2 weeks, starting 3 weeks after the 4th dose of induction therapy or after Day 113 if the 4th dose of induction therapy had not been administered due to treatment delays.
|
Arm I-3: IPI3 + NIV1
n=47 Participants
Induction: Nivolumab 1 mg/kg was administered as a 1-hour IV infusion followed by Ipilimumab 3 mg/kg administered IV infusion over 90 minutes every 3 weeks for 4 doses.
Maintenance: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion every 2 weeks, starting 3 weeks after the 4th dose of induction therapy or after Day 113 if the 4th dose of induction therapy had not been administered due to treatment delays.
|
Arm IN-3: IPI3 + NIV3
n=6 Participants
Induction: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion followed by Ipilimumab 3 mg/kg administered IV infusion over 90 minutes every 3 weeks for 4 doses.
Maintenance: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion every 2 weeks, starting 3 weeks after the 4th dose of induction therapy or after Day 113 if the 4th dose of induction therapy had not been administered due to treatment delays.
|
|---|---|---|---|---|---|---|
|
Duration of Response (DOR)
|
45.6 weeks
Interval 18.14 to
Upper 95% CI not reached
|
78.1 weeks
Interval 36.14 to
Upper 95% CI not reached
|
30.1 weeks
Interval 12.14 to 174.14
|
88.7 weeks
Interval 37.14 to
Upper 95% CI not reached
|
85.9 weeks
Interval 35.14 to
Upper 95% CI not reached
|
NA weeks
No participants in this arm achieved BOR of PR or CR
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: All treated participants
Rate of PFS at week 24 was defined as the proportion of participants remaining progression free or surviving at 24 weeks, calculated by the product-limit method (Kaplan-Meier estimate) which took into account censored data. Participants who did not have any on-study tumor assessment and did not die were censored on the date of first dose of study medication.
Outcome measures
| Measure |
Arm S: SUN + NIV2
n=7 Participants
Nivolumab 2 mg/kg administered on Day 1 and 22 of each 6 week (42 day) cycle as a 1-hour IV infusion followed 60 minutes later with Sunitinib 50 mg orally on Day 1 - 28 of each 42 day cycle until Progressive Disease (PD), toxicity or discontinuation for other reasons.
|
Arm S: SUN + NIV5
n=26 Participants
Nivolumab 5 mg/kg administered on Day 1 and 22 of each 6 week (42 day) cycle as a 1-hour IV infusion followed 60 minutes later with Sunitinib 50 mg orally on Day 1 - 28 of each 42 day cycle until Progressive Disease (PD), toxicity or discontinuation for other reasons.
|
Arm P: PAZ + NIV2
n=20 Participants
Nivolumab 2 mg/kg administered on Day 1 and 22 of each 6 week (42 day) cycle as a 1-hour IV infusion followed 60 minutes later with Pazopanib 800 mg orally on Day 1 - 42 of each 42 day cycle until Progressive Disease (PD), toxicity or discontinuation for other reasons.
|
Arm I-1: IPI1 + NIV3
n=47 Participants
Induction: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion followed by Ipilimumab 1 mg/kg administered IV infusion over 90 minutes every 3 weeks for 4 doses.
Maintenance: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion every 2 weeks, starting 3 weeks after the 4th dose of induction therapy or after Day 113 if the 4th dose of induction therapy had not been administered due to treatment delays.
|
Arm I-3: IPI3 + NIV1
n=47 Participants
Induction: Nivolumab 1 mg/kg was administered as a 1-hour IV infusion followed by Ipilimumab 3 mg/kg administered IV infusion over 90 minutes every 3 weeks for 4 doses.
Maintenance: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion every 2 weeks, starting 3 weeks after the 4th dose of induction therapy or after Day 113 if the 4th dose of induction therapy had not been administered due to treatment delays.
|
Arm IN-3: IPI3 + NIV3
n=6 Participants
Induction: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion followed by Ipilimumab 3 mg/kg administered IV infusion over 90 minutes every 3 weeks for 4 doses.
Maintenance: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion every 2 weeks, starting 3 weeks after the 4th dose of induction therapy or after Day 113 if the 4th dose of induction therapy had not been administered due to treatment delays.
|
|---|---|---|---|---|---|---|
|
Rate of Progression-free Survival (PFS) at Week 24
|
100 Percentage of participants with PFS
Interval 100.0 to 100.0
|
72.9 Percentage of participants with PFS
Interval 49.3 to 86.8
|
54.9 Percentage of participants with PFS
Interval 29.4 to 74.6
|
55.6 Percentage of participants with PFS
Interval 40.0 to 68.6
|
63.8 Percentage of participants with PFS
Interval 48.4 to 75.7
|
NA Percentage of participants with PFS
PFS rate at 24 weeks was not calculated for this arm
|
SECONDARY outcome
Timeframe: From date of first dose to date of disease progression or death, whichever occurred first (assessed up to March 2016, approximately 49 months)Population: All treated participants
PFS was defined as the time from the date of first dose of study medication to the date of first disease progression or death. Participants who did not have any on-study tumor assessment and did not die were censored on the date of first dose of study medication.
Outcome measures
| Measure |
Arm S: SUN + NIV2
n=7 Participants
Nivolumab 2 mg/kg administered on Day 1 and 22 of each 6 week (42 day) cycle as a 1-hour IV infusion followed 60 minutes later with Sunitinib 50 mg orally on Day 1 - 28 of each 42 day cycle until Progressive Disease (PD), toxicity or discontinuation for other reasons.
|
Arm S: SUN + NIV5
n=26 Participants
Nivolumab 5 mg/kg administered on Day 1 and 22 of each 6 week (42 day) cycle as a 1-hour IV infusion followed 60 minutes later with Sunitinib 50 mg orally on Day 1 - 28 of each 42 day cycle until Progressive Disease (PD), toxicity or discontinuation for other reasons.
|
Arm P: PAZ + NIV2
n=20 Participants
Nivolumab 2 mg/kg administered on Day 1 and 22 of each 6 week (42 day) cycle as a 1-hour IV infusion followed 60 minutes later with Pazopanib 800 mg orally on Day 1 - 42 of each 42 day cycle until Progressive Disease (PD), toxicity or discontinuation for other reasons.
|
Arm I-1: IPI1 + NIV3
n=47 Participants
Induction: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion followed by Ipilimumab 1 mg/kg administered IV infusion over 90 minutes every 3 weeks for 4 doses.
Maintenance: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion every 2 weeks, starting 3 weeks after the 4th dose of induction therapy or after Day 113 if the 4th dose of induction therapy had not been administered due to treatment delays.
|
Arm I-3: IPI3 + NIV1
n=47 Participants
Induction: Nivolumab 1 mg/kg was administered as a 1-hour IV infusion followed by Ipilimumab 3 mg/kg administered IV infusion over 90 minutes every 3 weeks for 4 doses.
Maintenance: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion every 2 weeks, starting 3 weeks after the 4th dose of induction therapy or after Day 113 if the 4th dose of induction therapy had not been administered due to treatment delays.
|
Arm IN-3: IPI3 + NIV3
n=6 Participants
Induction: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion followed by Ipilimumab 3 mg/kg administered IV infusion over 90 minutes every 3 weeks for 4 doses.
Maintenance: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion every 2 weeks, starting 3 weeks after the 4th dose of induction therapy or after Day 113 if the 4th dose of induction therapy had not been administered due to treatment delays.
|
|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS)
|
11.3 months
Interval 7.62 to
Upper 95% CI not reached
|
12.7 months
Interval 5.55 to 19.38
|
7.2 months
Interval 2.79 to 11.07
|
7.7 months
Interval 3.71 to 14.29
|
9.4 months
Interval 5.62 to 18.63
|
8.5 months
Interval 1.31 to
Upper 95% CI not reached
|
Adverse Events
SUNITINIB+NIVOLUMAB
Serious events: 19 serious events
Other events: 33 other events
Deaths: 0 deaths
PAZOPANIB+NIVOLUMAB
Serious events: 13 serious events
Other events: 20 other events
Deaths: 0 deaths
NIVO 3+IPI 1 (MG/KG)
Serious events: 29 serious events
Other events: 47 other events
Deaths: 0 deaths
NIVO 1+IPI 3 (MG/KG)
Serious events: 30 serious events
Other events: 46 other events
Deaths: 0 deaths
NIVO 3+IPI 3 (MG/KG)
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SUNITINIB+NIVOLUMAB
n=33 participants at risk
Nivolumab (2mg/kg or 5mg/kg)administered on Day 1 and 22 of each 6 week (42 day) cycle as a 1-hour IV infusion followed 60 minutes later with Sunitinib 50 mg orally on Day 1 - 28 of each 42 day cycle until Progressive Disease (PD), toxicity or discontinuation for other reasons.
|
PAZOPANIB+NIVOLUMAB
n=20 participants at risk
Nivolumab 2 mg/kg administered on Day 1 and 22 of each 6 week (42 day) cycle as a 1-hour IV infusion followed 60 minutes later with Pazopanib 800 mg orally on Day 1 - 42 of each 42 day cycle until Progressive Disease (PD), toxicity or discontinuation for other reasons.
|
NIVO 3+IPI 1 (MG/KG)
n=47 participants at risk
Induction: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion followed by Ipilimumab 1 mg/kg administered IV infusion over 90 minutes every 3 weeks for 4 doses.
Maintenance: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion every 2 weeks, starting 3 weeks after the 4th dose of induction therapy or after Day 113 if the 4th dose of induction therapy had not been administered due to treatment delays.
|
NIVO 1+IPI 3 (MG/KG)
n=47 participants at risk
Induction: Nivolumab 1 mg/kg was administered as a 1-hour IV infusion followed by Ipilimumab 3 mg/kg administered IV infusion over 90 minutes every 3 weeks for 4 doses.
Maintenance: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion every 2 weeks, starting 3 weeks after the 4th dose of induction therapy or after Day 113 if the 4th dose of induction therapy had not been administered due to treatment delays.
|
NIVO 3+IPI 3 (MG/KG)
n=6 participants at risk
Induction: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion followed by Ipilimumab 3 mg/kg administered IV infusion over 90 minutes every 3 weeks for 4 doses.
Maintenance: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion every 2 weeks, starting 3 weeks after the 4th dose of induction therapy or after Day 113 if the 4th dose of induction therapy had not been administered due to treatment delays.
|
|---|---|---|---|---|---|
|
Investigations
Platelet count decreased
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Investigations
Transaminases increased
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Metabolism and nutrition disorders
Dehydration
|
6.1%
2/33 • From first dose to date of last dose plus 100 days
|
10.0%
2/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
9.1%
3/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Blood and lymphatic system disorders
Methaemoglobinaemia
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Endocrine disorders
Hypopituitarism
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Eye disorders
Diplopia
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Gastrointestinal disorders
Autoimmune colitis
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
12.8%
6/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Gastrointestinal disorders
Diarrhoea
|
6.1%
2/33 • From first dose to date of last dose plus 100 days
|
10.0%
2/20 • From first dose to date of last dose plus 100 days
|
8.5%
4/47 • From first dose to date of last dose plus 100 days
|
12.8%
6/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Gastrointestinal disorders
Erosive duodenitis
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
General disorders
Chills
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
General disorders
Hernia
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
General disorders
Mucosal ulceration
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
General disorders
Pain
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
8.5%
4/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
General disorders
Pyrexia
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
10.0%
2/20 • From first dose to date of last dose plus 100 days
|
8.5%
4/47 • From first dose to date of last dose plus 100 days
|
6.4%
3/47 • From first dose to date of last dose plus 100 days
|
33.3%
2/6 • From first dose to date of last dose plus 100 days
|
|
General disorders
Sudden death
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Hepatobiliary disorders
Hepatitis acute
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Infections and infestations
Lung infection
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Infections and infestations
Pneumonia
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
10.0%
2/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Infections and infestations
Pneumonia legionella
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Infections and infestations
Skin infection
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Infections and infestations
Viral infection
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
8.5%
4/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
8.5%
4/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Investigations
Blood bilirubin increased
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Investigations
Blood creatinine increased
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Investigations
Lipase increased
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
10.0%
2/20 • From first dose to date of last dose plus 100 days
|
12.8%
6/47 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour flare
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Nervous system disorders
Headache
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Nervous system disorders
Neuropathy peripheral
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Nervous system disorders
Peripheral motor neuropathy
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Nervous system disorders
Seizure
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Nervous system disorders
Syncope
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Nervous system disorders
Transient global amnesia
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Renal and urinary disorders
Acute kidney injury
|
9.1%
3/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
6.4%
3/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
8.5%
4/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Vascular disorders
Haemorrhage
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Vascular disorders
Hypertension
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Vascular disorders
Hypotension
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Vascular disorders
Thrombosis
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Infections and infestations
Localised infection
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
Other adverse events
| Measure |
SUNITINIB+NIVOLUMAB
n=33 participants at risk
Nivolumab (2mg/kg or 5mg/kg)administered on Day 1 and 22 of each 6 week (42 day) cycle as a 1-hour IV infusion followed 60 minutes later with Sunitinib 50 mg orally on Day 1 - 28 of each 42 day cycle until Progressive Disease (PD), toxicity or discontinuation for other reasons.
|
PAZOPANIB+NIVOLUMAB
n=20 participants at risk
Nivolumab 2 mg/kg administered on Day 1 and 22 of each 6 week (42 day) cycle as a 1-hour IV infusion followed 60 minutes later with Pazopanib 800 mg orally on Day 1 - 42 of each 42 day cycle until Progressive Disease (PD), toxicity or discontinuation for other reasons.
|
NIVO 3+IPI 1 (MG/KG)
n=47 participants at risk
Induction: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion followed by Ipilimumab 1 mg/kg administered IV infusion over 90 minutes every 3 weeks for 4 doses.
Maintenance: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion every 2 weeks, starting 3 weeks after the 4th dose of induction therapy or after Day 113 if the 4th dose of induction therapy had not been administered due to treatment delays.
|
NIVO 1+IPI 3 (MG/KG)
n=47 participants at risk
Induction: Nivolumab 1 mg/kg was administered as a 1-hour IV infusion followed by Ipilimumab 3 mg/kg administered IV infusion over 90 minutes every 3 weeks for 4 doses.
Maintenance: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion every 2 weeks, starting 3 weeks after the 4th dose of induction therapy or after Day 113 if the 4th dose of induction therapy had not been administered due to treatment delays.
|
NIVO 3+IPI 3 (MG/KG)
n=6 participants at risk
Induction: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion followed by Ipilimumab 3 mg/kg administered IV infusion over 90 minutes every 3 weeks for 4 doses.
Maintenance: Nivolumab 3 mg/kg was administered as a 1-hour IV infusion every 2 weeks, starting 3 weeks after the 4th dose of induction therapy or after Day 113 if the 4th dose of induction therapy had not been administered due to treatment delays.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
24.2%
8/33 • From first dose to date of last dose plus 100 days
|
15.0%
3/20 • From first dose to date of last dose plus 100 days
|
14.9%
7/47 • From first dose to date of last dose plus 100 days
|
21.3%
10/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Blood and lymphatic system disorders
Leukopenia
|
9.1%
3/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Blood and lymphatic system disorders
Neutropenia
|
15.2%
5/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.1%
4/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Cardiac disorders
Palpitations
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
12.8%
6/47 • From first dose to date of last dose plus 100 days
|
6.4%
3/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Cardiac disorders
Tachycardia
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
10.6%
5/47 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Ear and labyrinth disorders
Tinnitus
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
10.0%
2/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
12.8%
6/47 • From first dose to date of last dose plus 100 days
|
33.3%
2/6 • From first dose to date of last dose plus 100 days
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Endocrine disorders
Endocrine disorder
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Endocrine disorders
Hyperthyroidism
|
15.2%
5/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
6.4%
3/47 • From first dose to date of last dose plus 100 days
|
17.0%
8/47 • From first dose to date of last dose plus 100 days
|
50.0%
3/6 • From first dose to date of last dose plus 100 days
|
|
Endocrine disorders
Hypothyroidism
|
30.3%
10/33 • From first dose to date of last dose plus 100 days
|
20.0%
4/20 • From first dose to date of last dose plus 100 days
|
21.3%
10/47 • From first dose to date of last dose plus 100 days
|
27.7%
13/47 • From first dose to date of last dose plus 100 days
|
83.3%
5/6 • From first dose to date of last dose plus 100 days
|
|
Endocrine disorders
Lymphocytic hypophysitis
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Eye disorders
Dry eye
|
6.1%
2/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Eye disorders
Eye pain
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Eye disorders
Lacrimation increased
|
12.1%
4/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
6.4%
3/47 • From first dose to date of last dose plus 100 days
|
10.6%
5/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Eye disorders
Ocular hyperaemia
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Eye disorders
Periorbital oedema
|
15.2%
5/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Eye disorders
Photopsia
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
10.0%
2/20 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Eye disorders
Vision blurred
|
6.1%
2/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
12.8%
6/47 • From first dose to date of last dose plus 100 days
|
10.6%
5/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Eye disorders
Visual impairment
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Eye disorders
Vitreous floaters
|
6.1%
2/33 • From first dose to date of last dose plus 100 days
|
10.0%
2/20 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Eye disorders
Vitreous haemorrhage
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Gastrointestinal disorders
Abdominal distension
|
9.1%
3/33 • From first dose to date of last dose plus 100 days
|
20.0%
4/20 • From first dose to date of last dose plus 100 days
|
8.5%
4/47 • From first dose to date of last dose plus 100 days
|
10.6%
5/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Gastrointestinal disorders
Abdominal pain
|
15.2%
5/33 • From first dose to date of last dose plus 100 days
|
35.0%
7/20 • From first dose to date of last dose plus 100 days
|
21.3%
10/47 • From first dose to date of last dose plus 100 days
|
25.5%
12/47 • From first dose to date of last dose plus 100 days
|
33.3%
2/6 • From first dose to date of last dose plus 100 days
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.1%
3/33 • From first dose to date of last dose plus 100 days
|
10.0%
2/20 • From first dose to date of last dose plus 100 days
|
8.5%
4/47 • From first dose to date of last dose plus 100 days
|
6.4%
3/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Gastrointestinal disorders
Anal inflammation
|
6.1%
2/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Gastrointestinal disorders
Autoimmune colitis
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Gastrointestinal disorders
Breath odour
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Gastrointestinal disorders
Constipation
|
27.3%
9/33 • From first dose to date of last dose plus 100 days
|
40.0%
8/20 • From first dose to date of last dose plus 100 days
|
29.8%
14/47 • From first dose to date of last dose plus 100 days
|
29.8%
14/47 • From first dose to date of last dose plus 100 days
|
33.3%
2/6 • From first dose to date of last dose plus 100 days
|
|
Gastrointestinal disorders
Defaecation urgency
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Gastrointestinal disorders
Diarrhoea
|
63.6%
21/33 • From first dose to date of last dose plus 100 days
|
70.0%
14/20 • From first dose to date of last dose plus 100 days
|
25.5%
12/47 • From first dose to date of last dose plus 100 days
|
53.2%
25/47 • From first dose to date of last dose plus 100 days
|
83.3%
5/6 • From first dose to date of last dose plus 100 days
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
11/33 • From first dose to date of last dose plus 100 days
|
10.0%
2/20 • From first dose to date of last dose plus 100 days
|
10.6%
5/47 • From first dose to date of last dose plus 100 days
|
17.0%
8/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
11/33 • From first dose to date of last dose plus 100 days
|
25.0%
5/20 • From first dose to date of last dose plus 100 days
|
12.8%
6/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
33.3%
2/6 • From first dose to date of last dose plus 100 days
|
|
Gastrointestinal disorders
Dysphagia
|
6.1%
2/33 • From first dose to date of last dose plus 100 days
|
15.0%
3/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Gastrointestinal disorders
Flatulence
|
18.2%
6/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
10.6%
5/47 • From first dose to date of last dose plus 100 days
|
6.4%
3/47 • From first dose to date of last dose plus 100 days
|
33.3%
2/6 • From first dose to date of last dose plus 100 days
|
|
Gastrointestinal disorders
Gastritis
|
9.1%
3/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
27.3%
9/33 • From first dose to date of last dose plus 100 days
|
15.0%
3/20 • From first dose to date of last dose plus 100 days
|
8.5%
4/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Gastrointestinal disorders
Glossodynia
|
12.1%
4/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Gastrointestinal disorders
Haemorrhoids
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
6.4%
3/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Gastrointestinal disorders
Mouth ulceration
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Gastrointestinal disorders
Nausea
|
60.6%
20/33 • From first dose to date of last dose plus 100 days
|
80.0%
16/20 • From first dose to date of last dose plus 100 days
|
40.4%
19/47 • From first dose to date of last dose plus 100 days
|
55.3%
26/47 • From first dose to date of last dose plus 100 days
|
66.7%
4/6 • From first dose to date of last dose plus 100 days
|
|
Gastrointestinal disorders
Oral pain
|
15.2%
5/33 • From first dose to date of last dose plus 100 days
|
20.0%
4/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Gastrointestinal disorders
Stomatitis
|
24.2%
8/33 • From first dose to date of last dose plus 100 days
|
10.0%
2/20 • From first dose to date of last dose plus 100 days
|
14.9%
7/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
33.3%
2/6 • From first dose to date of last dose plus 100 days
|
|
Gastrointestinal disorders
Toothache
|
6.1%
2/33 • From first dose to date of last dose plus 100 days
|
10.0%
2/20 • From first dose to date of last dose plus 100 days
|
6.4%
3/47 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Gastrointestinal disorders
Vomiting
|
30.3%
10/33 • From first dose to date of last dose plus 100 days
|
45.0%
9/20 • From first dose to date of last dose plus 100 days
|
31.9%
15/47 • From first dose to date of last dose plus 100 days
|
29.8%
14/47 • From first dose to date of last dose plus 100 days
|
50.0%
3/6 • From first dose to date of last dose plus 100 days
|
|
General disorders
Asthenia
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
6.4%
3/47 • From first dose to date of last dose plus 100 days
|
8.5%
4/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
General disorders
Chest discomfort
|
9.1%
3/33 • From first dose to date of last dose plus 100 days
|
10.0%
2/20 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
General disorders
Chest pain
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
15.0%
3/20 • From first dose to date of last dose plus 100 days
|
10.6%
5/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
General disorders
Chills
|
24.2%
8/33 • From first dose to date of last dose plus 100 days
|
30.0%
6/20 • From first dose to date of last dose plus 100 days
|
27.7%
13/47 • From first dose to date of last dose plus 100 days
|
19.1%
9/47 • From first dose to date of last dose plus 100 days
|
50.0%
3/6 • From first dose to date of last dose plus 100 days
|
|
General disorders
Face oedema
|
12.1%
4/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
General disorders
Fatigue
|
87.9%
29/33 • From first dose to date of last dose plus 100 days
|
75.0%
15/20 • From first dose to date of last dose plus 100 days
|
66.0%
31/47 • From first dose to date of last dose plus 100 days
|
74.5%
35/47 • From first dose to date of last dose plus 100 days
|
100.0%
6/6 • From first dose to date of last dose plus 100 days
|
|
General disorders
Generalised oedema
|
6.1%
2/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
General disorders
Influenza like illness
|
9.1%
3/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
General disorders
Localised oedema
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
General disorders
Malaise
|
6.1%
2/33 • From first dose to date of last dose plus 100 days
|
10.0%
2/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
General disorders
Mucosal inflammation
|
33.3%
11/33 • From first dose to date of last dose plus 100 days
|
25.0%
5/20 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
8.5%
4/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
General disorders
Non-cardiac chest pain
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
General disorders
Oedema
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
General disorders
Oedema peripheral
|
33.3%
11/33 • From first dose to date of last dose plus 100 days
|
25.0%
5/20 • From first dose to date of last dose plus 100 days
|
25.5%
12/47 • From first dose to date of last dose plus 100 days
|
27.7%
13/47 • From first dose to date of last dose plus 100 days
|
50.0%
3/6 • From first dose to date of last dose plus 100 days
|
|
General disorders
Pain
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
10.0%
2/20 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
General disorders
Pyrexia
|
30.3%
10/33 • From first dose to date of last dose plus 100 days
|
35.0%
7/20 • From first dose to date of last dose plus 100 days
|
38.3%
18/47 • From first dose to date of last dose plus 100 days
|
23.4%
11/47 • From first dose to date of last dose plus 100 days
|
100.0%
6/6 • From first dose to date of last dose plus 100 days
|
|
General disorders
Sensation of foreign body
|
6.1%
2/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
General disorders
Temperature intolerance
|
6.1%
2/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Infections and infestations
Bronchitis
|
9.1%
3/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Infections and infestations
Ear infection
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Infections and infestations
Gingivitis
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Infections and infestations
Groin abscess
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Infections and infestations
Infected bite
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Infections and infestations
Lung infection
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Infections and infestations
Pneumonia
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
10.0%
2/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Infections and infestations
Rhinitis
|
6.1%
2/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Infections and infestations
Sinusitis
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
8.5%
4/47 • From first dose to date of last dose plus 100 days
|
6.4%
3/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Infections and infestations
Skin infection
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Infections and infestations
Tinea infection
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Infections and infestations
Tooth infection
|
9.1%
3/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Infections and infestations
Upper respiratory tract infection
|
24.2%
8/33 • From first dose to date of last dose plus 100 days
|
35.0%
7/20 • From first dose to date of last dose plus 100 days
|
19.1%
9/47 • From first dose to date of last dose plus 100 days
|
14.9%
7/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Infections and infestations
Urinary tract infection
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
10.0%
2/20 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
6.4%
3/47 • From first dose to date of last dose plus 100 days
|
33.3%
2/6 • From first dose to date of last dose plus 100 days
|
|
Infections and infestations
Vulvitis
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Injury, poisoning and procedural complications
Contusion
|
15.2%
5/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
6.4%
3/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Injury, poisoning and procedural complications
Fall
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
10.6%
5/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
6.4%
3/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
15.0%
3/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
6.1%
2/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
6.4%
3/47 • From first dose to date of last dose plus 100 days
|
6.4%
3/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Investigations
Alanine aminotransferase increased
|
39.4%
13/33 • From first dose to date of last dose plus 100 days
|
25.0%
5/20 • From first dose to date of last dose plus 100 days
|
17.0%
8/47 • From first dose to date of last dose plus 100 days
|
34.0%
16/47 • From first dose to date of last dose plus 100 days
|
50.0%
3/6 • From first dose to date of last dose plus 100 days
|
|
Investigations
Amylase increased
|
15.2%
5/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
8.5%
4/47 • From first dose to date of last dose plus 100 days
|
17.0%
8/47 • From first dose to date of last dose plus 100 days
|
33.3%
2/6 • From first dose to date of last dose plus 100 days
|
|
Investigations
Aspartate aminotransferase increased
|
36.4%
12/33 • From first dose to date of last dose plus 100 days
|
30.0%
6/20 • From first dose to date of last dose plus 100 days
|
19.1%
9/47 • From first dose to date of last dose plus 100 days
|
29.8%
14/47 • From first dose to date of last dose plus 100 days
|
50.0%
3/6 • From first dose to date of last dose plus 100 days
|
|
Investigations
Blood alkaline phosphatase increased
|
15.2%
5/33 • From first dose to date of last dose plus 100 days
|
15.0%
3/20 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
8.5%
4/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Investigations
Blood bilirubin increased
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
6.4%
3/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Investigations
Blood creatinine increased
|
36.4%
12/33 • From first dose to date of last dose plus 100 days
|
10.0%
2/20 • From first dose to date of last dose plus 100 days
|
14.9%
7/47 • From first dose to date of last dose plus 100 days
|
19.1%
9/47 • From first dose to date of last dose plus 100 days
|
33.3%
2/6 • From first dose to date of last dose plus 100 days
|
|
Investigations
Gamma-glutamyltransferase increased
|
6.1%
2/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Investigations
Lipase increased
|
6.1%
2/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
23.4%
11/47 • From first dose to date of last dose plus 100 days
|
40.4%
19/47 • From first dose to date of last dose plus 100 days
|
33.3%
2/6 • From first dose to date of last dose plus 100 days
|
|
Investigations
Lymphocyte count decreased
|
27.3%
9/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
8.5%
4/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Investigations
Neutrophil count decreased
|
18.2%
6/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Investigations
Platelet count decreased
|
18.2%
6/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
6.4%
3/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Investigations
Weight decreased
|
12.1%
4/33 • From first dose to date of last dose plus 100 days
|
20.0%
4/20 • From first dose to date of last dose plus 100 days
|
10.6%
5/47 • From first dose to date of last dose plus 100 days
|
23.4%
11/47 • From first dose to date of last dose plus 100 days
|
66.7%
4/6 • From first dose to date of last dose plus 100 days
|
|
Investigations
Weight increased
|
9.1%
3/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
14.9%
7/47 • From first dose to date of last dose plus 100 days
|
8.5%
4/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Investigations
White blood cell count decreased
|
21.2%
7/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
48.5%
16/33 • From first dose to date of last dose plus 100 days
|
55.0%
11/20 • From first dose to date of last dose plus 100 days
|
27.7%
13/47 • From first dose to date of last dose plus 100 days
|
40.4%
19/47 • From first dose to date of last dose plus 100 days
|
83.3%
5/6 • From first dose to date of last dose plus 100 days
|
|
Metabolism and nutrition disorders
Dehydration
|
21.2%
7/33 • From first dose to date of last dose plus 100 days
|
30.0%
6/20 • From first dose to date of last dose plus 100 days
|
14.9%
7/47 • From first dose to date of last dose plus 100 days
|
19.1%
9/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Metabolism and nutrition disorders
Gout
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
10.0%
2/20 • From first dose to date of last dose plus 100 days
|
8.5%
4/47 • From first dose to date of last dose plus 100 days
|
10.6%
5/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
24.2%
8/33 • From first dose to date of last dose plus 100 days
|
20.0%
4/20 • From first dose to date of last dose plus 100 days
|
14.9%
7/47 • From first dose to date of last dose plus 100 days
|
17.0%
8/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
9.1%
3/33 • From first dose to date of last dose plus 100 days
|
10.0%
2/20 • From first dose to date of last dose plus 100 days
|
10.6%
5/47 • From first dose to date of last dose plus 100 days
|
8.5%
4/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
9.1%
3/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
10.6%
5/47 • From first dose to date of last dose plus 100 days
|
33.3%
2/6 • From first dose to date of last dose plus 100 days
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
9.1%
3/33 • From first dose to date of last dose plus 100 days
|
10.0%
2/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
8.5%
4/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
10.0%
2/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
6.4%
3/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
6.4%
3/47 • From first dose to date of last dose plus 100 days
|
8.5%
4/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
9.1%
3/33 • From first dose to date of last dose plus 100 days
|
25.0%
5/20 • From first dose to date of last dose plus 100 days
|
6.4%
3/47 • From first dose to date of last dose plus 100 days
|
12.8%
6/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
27.3%
9/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
12.8%
6/47 • From first dose to date of last dose plus 100 days
|
12.8%
6/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
9.1%
3/33 • From first dose to date of last dose plus 100 days
|
10.0%
2/20 • From first dose to date of last dose plus 100 days
|
6.4%
3/47 • From first dose to date of last dose plus 100 days
|
12.8%
6/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
36.4%
12/33 • From first dose to date of last dose plus 100 days
|
45.0%
9/20 • From first dose to date of last dose plus 100 days
|
51.1%
24/47 • From first dose to date of last dose plus 100 days
|
25.5%
12/47 • From first dose to date of last dose plus 100 days
|
83.3%
5/6 • From first dose to date of last dose plus 100 days
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
21.2%
7/33 • From first dose to date of last dose plus 100 days
|
30.0%
6/20 • From first dose to date of last dose plus 100 days
|
31.9%
15/47 • From first dose to date of last dose plus 100 days
|
17.0%
8/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
10.0%
2/20 • From first dose to date of last dose plus 100 days
|
17.0%
8/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Musculoskeletal and connective tissue disorders
Lower extremity mass
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
12.1%
4/33 • From first dose to date of last dose plus 100 days
|
25.0%
5/20 • From first dose to date of last dose plus 100 days
|
6.4%
3/47 • From first dose to date of last dose plus 100 days
|
8.5%
4/47 • From first dose to date of last dose plus 100 days
|
50.0%
3/6 • From first dose to date of last dose plus 100 days
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
10.0%
2/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.1%
2/33 • From first dose to date of last dose plus 100 days
|
10.0%
2/20 • From first dose to date of last dose plus 100 days
|
6.4%
3/47 • From first dose to date of last dose plus 100 days
|
12.8%
6/47 • From first dose to date of last dose plus 100 days
|
33.3%
2/6 • From first dose to date of last dose plus 100 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.1%
2/33 • From first dose to date of last dose plus 100 days
|
25.0%
5/20 • From first dose to date of last dose plus 100 days
|
12.8%
6/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.1%
2/33 • From first dose to date of last dose plus 100 days
|
20.0%
4/20 • From first dose to date of last dose plus 100 days
|
6.4%
3/47 • From first dose to date of last dose plus 100 days
|
10.6%
5/47 • From first dose to date of last dose plus 100 days
|
33.3%
2/6 • From first dose to date of last dose plus 100 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
6.1%
2/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
8.5%
4/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
30.3%
10/33 • From first dose to date of last dose plus 100 days
|
25.0%
5/20 • From first dose to date of last dose plus 100 days
|
23.4%
11/47 • From first dose to date of last dose plus 100 days
|
21.3%
10/47 • From first dose to date of last dose plus 100 days
|
66.7%
4/6 • From first dose to date of last dose plus 100 days
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
10.0%
2/20 • From first dose to date of last dose plus 100 days
|
17.0%
8/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
36.4%
12/33 • From first dose to date of last dose plus 100 days
|
30.0%
6/20 • From first dose to date of last dose plus 100 days
|
17.0%
8/47 • From first dose to date of last dose plus 100 days
|
10.6%
5/47 • From first dose to date of last dose plus 100 days
|
33.3%
2/6 • From first dose to date of last dose plus 100 days
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Nervous system disorders
Ataxia
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Nervous system disorders
Cerebellar syndrome
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
6.4%
3/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Nervous system disorders
Disturbance in attention
|
6.1%
2/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Nervous system disorders
Dizziness
|
33.3%
11/33 • From first dose to date of last dose plus 100 days
|
15.0%
3/20 • From first dose to date of last dose plus 100 days
|
21.3%
10/47 • From first dose to date of last dose plus 100 days
|
25.5%
12/47 • From first dose to date of last dose plus 100 days
|
33.3%
2/6 • From first dose to date of last dose plus 100 days
|
|
Nervous system disorders
Dysgeusia
|
63.6%
21/33 • From first dose to date of last dose plus 100 days
|
50.0%
10/20 • From first dose to date of last dose plus 100 days
|
10.6%
5/47 • From first dose to date of last dose plus 100 days
|
17.0%
8/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Nervous system disorders
Headache
|
39.4%
13/33 • From first dose to date of last dose plus 100 days
|
25.0%
5/20 • From first dose to date of last dose plus 100 days
|
31.9%
15/47 • From first dose to date of last dose plus 100 days
|
27.7%
13/47 • From first dose to date of last dose plus 100 days
|
66.7%
4/6 • From first dose to date of last dose plus 100 days
|
|
Nervous system disorders
Hyperaesthesia
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
10.0%
2/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Nervous system disorders
Neuropathy peripheral
|
12.1%
4/33 • From first dose to date of last dose plus 100 days
|
10.0%
2/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
6.4%
3/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Nervous system disorders
Paraesthesia
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
8.5%
4/47 • From first dose to date of last dose plus 100 days
|
6.4%
3/47 • From first dose to date of last dose plus 100 days
|
33.3%
2/6 • From first dose to date of last dose plus 100 days
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
6.4%
3/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Nervous system disorders
Restless legs syndrome
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Nervous system disorders
Sciatica
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
6.4%
3/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Nervous system disorders
Seizure
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Nervous system disorders
Somnolence
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Nervous system disorders
Syncope
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Nervous system disorders
Tremor
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
6.4%
3/47 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
33.3%
2/6 • From first dose to date of last dose plus 100 days
|
|
Psychiatric disorders
Anxiety
|
9.1%
3/33 • From first dose to date of last dose plus 100 days
|
10.0%
2/20 • From first dose to date of last dose plus 100 days
|
14.9%
7/47 • From first dose to date of last dose plus 100 days
|
8.5%
4/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Psychiatric disorders
Confusional state
|
6.1%
2/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Psychiatric disorders
Depression
|
12.1%
4/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
33.3%
2/6 • From first dose to date of last dose plus 100 days
|
|
Psychiatric disorders
Insomnia
|
15.2%
5/33 • From first dose to date of last dose plus 100 days
|
20.0%
4/20 • From first dose to date of last dose plus 100 days
|
19.1%
9/47 • From first dose to date of last dose plus 100 days
|
19.1%
9/47 • From first dose to date of last dose plus 100 days
|
50.0%
3/6 • From first dose to date of last dose plus 100 days
|
|
Psychiatric disorders
Irritability
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
6.4%
3/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Renal and urinary disorders
Acute kidney injury
|
9.1%
3/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Renal and urinary disorders
Haematuria
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
10.0%
2/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
6.4%
3/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Renal and urinary disorders
Pollakiuria
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
10.0%
2/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Renal and urinary disorders
Proteinuria
|
12.1%
4/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
6.4%
3/47 • From first dose to date of last dose plus 100 days
|
12.8%
6/47 • From first dose to date of last dose plus 100 days
|
33.3%
2/6 • From first dose to date of last dose plus 100 days
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
54.5%
18/33 • From first dose to date of last dose plus 100 days
|
65.0%
13/20 • From first dose to date of last dose plus 100 days
|
51.1%
24/47 • From first dose to date of last dose plus 100 days
|
29.8%
14/47 • From first dose to date of last dose plus 100 days
|
83.3%
5/6 • From first dose to date of last dose plus 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
12.1%
4/33 • From first dose to date of last dose plus 100 days
|
25.0%
5/20 • From first dose to date of last dose plus 100 days
|
14.9%
7/47 • From first dose to date of last dose plus 100 days
|
8.5%
4/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
36.4%
12/33 • From first dose to date of last dose plus 100 days
|
20.0%
4/20 • From first dose to date of last dose plus 100 days
|
27.7%
13/47 • From first dose to date of last dose plus 100 days
|
19.1%
9/47 • From first dose to date of last dose plus 100 days
|
33.3%
2/6 • From first dose to date of last dose plus 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea at rest
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
12.1%
4/33 • From first dose to date of last dose plus 100 days
|
15.0%
3/20 • From first dose to date of last dose plus 100 days
|
14.9%
7/47 • From first dose to date of last dose plus 100 days
|
8.5%
4/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
18.2%
6/33 • From first dose to date of last dose plus 100 days
|
10.0%
2/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
6.1%
2/33 • From first dose to date of last dose plus 100 days
|
10.0%
2/20 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
6.4%
3/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
6.4%
3/47 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
24.2%
8/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
19.1%
9/47 • From first dose to date of last dose plus 100 days
|
12.8%
6/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
9.1%
3/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
24.2%
8/33 • From first dose to date of last dose plus 100 days
|
15.0%
3/20 • From first dose to date of last dose plus 100 days
|
12.8%
6/47 • From first dose to date of last dose plus 100 days
|
10.6%
5/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
8.5%
4/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.1%
2/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
6.4%
3/47 • From first dose to date of last dose plus 100 days
|
10.6%
5/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
6.4%
3/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
6.1%
2/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
15.2%
5/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
17.0%
8/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
8.5%
4/47 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
6.1%
2/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
14.9%
7/47 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
10.0%
2/20 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Skin and subcutaneous tissue disorders
Blister
|
6.1%
2/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
6.4%
3/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
33.3%
11/33 • From first dose to date of last dose plus 100 days
|
15.0%
3/20 • From first dose to date of last dose plus 100 days
|
23.4%
11/47 • From first dose to date of last dose plus 100 days
|
8.5%
4/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Skin and subcutaneous tissue disorders
Dyshidrotic eczema
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Skin and subcutaneous tissue disorders
Erythema
|
9.1%
3/33 • From first dose to date of last dose plus 100 days
|
10.0%
2/20 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
8.5%
4/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
18.2%
6/33 • From first dose to date of last dose plus 100 days
|
20.0%
4/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Skin and subcutaneous tissue disorders
Hair growth abnormal
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
10.0%
2/20 • From first dose to date of last dose plus 100 days
|
10.6%
5/47 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
50.0%
3/6 • From first dose to date of last dose plus 100 days
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
6.1%
2/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
6.4%
3/47 • From first dose to date of last dose plus 100 days
|
8.5%
4/47 • From first dose to date of last dose plus 100 days
|
33.3%
2/6 • From first dose to date of last dose plus 100 days
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
39.4%
13/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
27.3%
9/33 • From first dose to date of last dose plus 100 days
|
45.0%
9/20 • From first dose to date of last dose plus 100 days
|
38.3%
18/47 • From first dose to date of last dose plus 100 days
|
44.7%
21/47 • From first dose to date of last dose plus 100 days
|
50.0%
3/6 • From first dose to date of last dose plus 100 days
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
27.3%
9/33 • From first dose to date of last dose plus 100 days
|
35.0%
7/20 • From first dose to date of last dose plus 100 days
|
38.3%
18/47 • From first dose to date of last dose plus 100 days
|
31.9%
15/47 • From first dose to date of last dose plus 100 days
|
66.7%
4/6 • From first dose to date of last dose plus 100 days
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
6.4%
3/47 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
30.3%
10/33 • From first dose to date of last dose plus 100 days
|
20.0%
4/20 • From first dose to date of last dose plus 100 days
|
14.9%
7/47 • From first dose to date of last dose plus 100 days
|
17.0%
8/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
8.5%
4/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
9.1%
3/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
6.1%
2/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
6.1%
2/33 • From first dose to date of last dose plus 100 days
|
10.0%
2/20 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
6.4%
3/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Skin and subcutaneous tissue disorders
Yellow skin
|
21.2%
7/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Vascular disorders
Deep vein thrombosis
|
6.1%
2/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Vascular disorders
Flushing
|
15.2%
5/33 • From first dose to date of last dose plus 100 days
|
15.0%
3/20 • From first dose to date of last dose plus 100 days
|
6.4%
3/47 • From first dose to date of last dose plus 100 days
|
12.8%
6/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Vascular disorders
Haematoma
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Vascular disorders
Hot flush
|
15.2%
5/33 • From first dose to date of last dose plus 100 days
|
10.0%
2/20 • From first dose to date of last dose plus 100 days
|
6.4%
3/47 • From first dose to date of last dose plus 100 days
|
8.5%
4/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Vascular disorders
Hypertension
|
51.5%
17/33 • From first dose to date of last dose plus 100 days
|
40.0%
8/20 • From first dose to date of last dose plus 100 days
|
8.5%
4/47 • From first dose to date of last dose plus 100 days
|
12.8%
6/47 • From first dose to date of last dose plus 100 days
|
50.0%
3/6 • From first dose to date of last dose plus 100 days
|
|
Vascular disorders
Hypotension
|
6.1%
2/33 • From first dose to date of last dose plus 100 days
|
20.0%
4/20 • From first dose to date of last dose plus 100 days
|
6.4%
3/47 • From first dose to date of last dose plus 100 days
|
12.8%
6/47 • From first dose to date of last dose plus 100 days
|
33.3%
2/6 • From first dose to date of last dose plus 100 days
|
|
Vascular disorders
Orthostatic hypertension
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Vascular disorders
Phlebitis
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Endocrine disorders
Autoimmune hypothyroidism
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Infections and infestations
Cellulitis
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Infections and infestations
Genital infection fungal
|
3.0%
1/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
2.1%
1/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
16.7%
1/6 • From first dose to date of last dose plus 100 days
|
|
Psychiatric disorders
Libido decreased
|
6.1%
2/33 • From first dose to date of last dose plus 100 days
|
0.00%
0/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
4.3%
2/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
0.00%
0/33 • From first dose to date of last dose plus 100 days
|
5.0%
1/20 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/47 • From first dose to date of last dose plus 100 days
|
0.00%
0/6 • From first dose to date of last dose plus 100 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER