Trial Outcomes & Findings for A Study of Two Different Doses of Cabozantinib (XL184) in Progressive, Metastatic Medullary Thyroid Cancer (NCT NCT01896479)
NCT ID: NCT01896479
Last Updated: 2025-09-02
Results Overview
PFS per BIRC per RECIST 1.1 was measured from randomization until the date of first documented disease progression or date of death from any cause, whichever came first, and was assessed for up to 31 months. The prespecified primary analysis was triggered by the required number of at least 150 events occurring in the ITT population, The data cutoff date for this event-driven analysis in the ITT population was when a total of 155 events were reported. Median PFS was calculated using the Kaplan-Meier estimates.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE4
Target enrollment
247 participants
Primary outcome timeframe
Median time of follow-up (from the date of randomization of the first participant through primary data cut off [15 July 2020]) was 30.2 months
Results posted on
2025-09-02
Participant Flow
Cabozantinib-matched placebo capsules and tablets were administered along with the corresponding tablets and capsules to maintain the blinding of the study treatment. Per prespecified analysis, all participants who died during the study met the study requirements of study completion. Therefore, none of the deaths that occurred during the study were recorded as leading to study discontinuation.
Participant milestones
| Measure |
Cabozantinib (XL184) 60 mg
Cabozantinib (XL184) 60 milligram (mg) tablets were administered with cabozantinib-matched placebo capsules orally once a day.
|
Cabozantinib (XL184) 140 mg
Cabozantinib (XL184) 140 mg capsules were administered with cabozantinib-matched placebo tablets administered orally once a day.
|
|---|---|---|
|
Overall Study
STARTED
|
123
|
124
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
123
|
124
|
|
Overall Study
COMPLETED
|
123
|
124
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Two Different Doses of Cabozantinib (XL184) in Progressive, Metastatic Medullary Thyroid Cancer
Baseline characteristics by cohort
| Measure |
Cabozantinib (XL184) 60 mg
n=123 Participants
Cabozantinib (XL184) 60 mg tablets were administered with cabozantinib-matched placebo capsules orally once a day.
|
Cabozantinib (XL184) 140 mg
n=124 Participants
Cabozantinib (XL184) 140 mg capsules were administered with cabozantinib-matched placebo tablets administered orally once a day.
|
Total
n=247 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
85 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
38 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
90 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
103 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
205 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
92 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
194 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
18 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
14 participants
n=5 Participants
|
16 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
6 participants
n=5 Participants
|
12 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
10 participants
n=5 Participants
|
7 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
5 participants
n=5 Participants
|
1 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
13 participants
n=5 Participants
|
17 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
9 participants
n=5 Participants
|
13 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
19 participants
n=5 Participants
|
20 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Region of Enrollment
France
|
21 participants
n=5 Participants
|
13 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Region of Enrollment
Croatia
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Median time of follow-up (from the date of randomization of the first participant through primary data cut off [15 July 2020]) was 30.2 monthsPopulation: Measured in the Intent-to-Treat (ITT) Population, which included all randomized participants.
PFS per BIRC per RECIST 1.1 was measured from randomization until the date of first documented disease progression or date of death from any cause, whichever came first, and was assessed for up to 31 months. The prespecified primary analysis was triggered by the required number of at least 150 events occurring in the ITT population, The data cutoff date for this event-driven analysis in the ITT population was when a total of 155 events were reported. Median PFS was calculated using the Kaplan-Meier estimates.
Outcome measures
| Measure |
Cabozantinib (XL184) 60 mg
n=123 Participants
Cabozantinib (XL184) 60 mg tablets were administered with cabozantinib-matched placebo capsules orally once a day.
|
Cabozantinib (XL184) 140 mg
n=124 Participants
Cabozantinib (XL184) 140 mg capsules were administered with cabozantinib-matched placebo tablets administered orally once a day.
|
|---|---|---|
|
Progression Free Survival (PFS) Per Blinded Independent Radiology Committee (BIRC) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
|
11 months
Interval 8.3 to 13.6
|
13.9 months
Interval 9.0 to 16.6
|
SECONDARY outcome
Timeframe: Median time of follow-up (from the date of randomization of the first participant through primary data cut off [15 July 2020]) was 30.2 monthsPopulation: Measured in the ITT Population, which included all randomized participants.
ORR per BIRC per RECIST 1.1 is the percentage of ITT participants who experienced a best overall response of complete response (CR) or partial response (PR), confirmed ≥ 28 days later, CR defined as disappearance of all non-target lesions. All lymph nodes must have been non-pathological in size (\<10 mm short axis). PR defined as unequivocal progression of non-target lesions. Unequivocal progression was to trump target lesion status. It must have been representative of overall disease status change, not a single lesion increase.
Outcome measures
| Measure |
Cabozantinib (XL184) 60 mg
n=123 Participants
Cabozantinib (XL184) 60 mg tablets were administered with cabozantinib-matched placebo capsules orally once a day.
|
Cabozantinib (XL184) 140 mg
n=124 Participants
Cabozantinib (XL184) 140 mg capsules were administered with cabozantinib-matched placebo tablets administered orally once a day.
|
|---|---|---|
|
Objective Response Rate (ORR) Per BIRC Per RECIST 1.1
|
33 percentage of participants
Interval 25.09 to 42.4
|
33 percentage of participants
Interval 24.88 to 42.08
|
Adverse Events
Cabozantinib (XL184) 60 mg
Serious events: 55 serious events
Other events: 122 other events
Deaths: 59 deaths
Cabozantinib (XL184) 140 mg
Serious events: 62 serious events
Other events: 123 other events
Deaths: 51 deaths
Serious adverse events
| Measure |
Cabozantinib (XL184) 60 mg
n=123 participants at risk
Cabozantinib (XL184) 60 mg tablets were administered with cabozantinib-matched placebo capsules orally once a day.
|
Cabozantinib (XL184) 140 mg
n=124 participants at risk
Cabozantinib (XL184) 140 mg capsules were administered with cabozantinib-matched placebo tablets administered orally once a day.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Vascular disorders
Hypertension
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Vascular disorders
Aortic dissection rupture
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Vascular disorders
Deep vein thrombosis
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Vascular disorders
Hypotension
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.4%
3/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Cardiac disorders
Cardiac failure
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Congenital, familial and genetic disorders
Tracheo-oesophageal fistula
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Endocrine disorders
Diabetes insipidus
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Endocrine disorders
Hypoparathyroidism
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.6%
2/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
1.6%
2/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
2.4%
3/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Gastrointestinal disorders
Anal fistula
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
1.6%
2/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
1.6%
2/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
1.6%
2/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Gastrointestinal disorders
Dysphagia
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Gastrointestinal disorders
Femoral hernia strangulated
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
General disorders
Asthenia
|
2.4%
3/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
General disorders
General physical health deterioration
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
1.6%
2/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
General disorders
Death
|
1.6%
2/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
General disorders
Mucosal inflammation
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
General disorders
Fatigue
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
General disorders
Malaise
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
General disorders
Oedema peripheral
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
General disorders
Pain
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
General disorders
Pyrexia
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
General disorders
Sudden death
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
1.6%
2/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Infections and infestations
Pneumonia
|
4.1%
5/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
4.0%
5/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Infections and infestations
Sepsis
|
2.4%
3/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
1.6%
2/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Infections and infestations
Peritonitis
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
1.6%
2/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Infections and infestations
Appendicitis
|
1.6%
2/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Infections and infestations
Abdominal abscess
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Infections and infestations
Campylobacter infection
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Infections and infestations
Diverticulitis
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Infections and infestations
Extradural abscess
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Infections and infestations
Perihepatic abscess
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Infections and infestations
Pneumonia streptococcal
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Infections and infestations
Rectal abscess
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Infections and infestations
Sialoadenitis
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Infections and infestations
Skin infection
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Infections and infestations
Urinary tract infection
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Investigations
Weight decreased
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Investigations
Amylase increased
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Investigations
Blood bilirubin increased
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Investigations
Platelet count decreased
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.6%
2/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
2.4%
3/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
1.6%
2/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
2.4%
3/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
1.6%
2/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Metabolism and nutrition disorders
Gout
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
1.6%
2/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
1.6%
2/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Musculoskeletal and connective tissue disorders
Bone lesion
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Medullary thyroid cancer
|
7.3%
9/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
7.3%
9/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute promyelocytic leukaemia
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemorrhagic tumour necrosis
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of ampulla of Vater
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer metastatic
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour necrosis
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Nervous system disorders
Aphasia
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Nervous system disorders
Cerebellar ischaemia
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Nervous system disorders
Ischaemic stroke
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Nervous system disorders
Seizure
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Nervous system disorders
Syncope
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Nervous system disorders
Vocal cord paralysis
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Psychiatric disorders
Confusional state
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Psychiatric disorders
Depression
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Psychiatric disorders
Suicide attempt
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.6%
2/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Renal and urinary disorders
Renal colic
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.81%
1/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal fistula
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Skin and subcutaneous tissue disorders
Ischaemic skin ulcer
|
0.81%
1/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
0.00%
0/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
Other adverse events
| Measure |
Cabozantinib (XL184) 60 mg
n=123 participants at risk
Cabozantinib (XL184) 60 mg tablets were administered with cabozantinib-matched placebo capsules orally once a day.
|
Cabozantinib (XL184) 140 mg
n=124 participants at risk
Cabozantinib (XL184) 140 mg capsules were administered with cabozantinib-matched placebo tablets administered orally once a day.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
13.8%
17/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
18.5%
23/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.6%
13/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
11.3%
14/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.7%
7/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
12.1%
15/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
9.8%
12/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
8.1%
10/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.3%
9/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
9.7%
12/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Cardiac disorders
Tachycardia
|
5.7%
7/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
4.8%
6/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Endocrine disorders
Hypothyroidism
|
14.6%
18/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
12.1%
15/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Gastrointestinal disorders
Diarrhoea
|
67.5%
83/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
71.8%
89/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Gastrointestinal disorders
Nausea
|
19.5%
24/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
32.3%
40/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Gastrointestinal disorders
Stomatitis
|
17.1%
21/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
25.0%
31/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Gastrointestinal disorders
Vomiting
|
13.0%
16/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
29.0%
36/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Gastrointestinal disorders
Abdominal pain
|
19.5%
24/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
21.8%
27/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Gastrointestinal disorders
Constipation
|
16.3%
20/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
18.5%
23/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
15.4%
19/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
9.7%
12/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Gastrointestinal disorders
Dry mouth
|
13.8%
17/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
8.1%
10/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Gastrointestinal disorders
Dyspepsia
|
9.8%
12/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
9.7%
12/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Gastrointestinal disorders
Toothache
|
7.3%
9/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
8.9%
11/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
8.1%
10/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
6.5%
8/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Gastrointestinal disorders
Haemorrhoids
|
7.3%
9/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
7.3%
9/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Gastrointestinal disorders
Dysphagia
|
6.5%
8/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
6.5%
8/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Gastrointestinal disorders
Mouth ulceration
|
4.1%
5/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
7.3%
9/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Gastrointestinal disorders
Oral pain
|
6.5%
8/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
4.8%
6/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
General disorders
Fatigue
|
35.0%
43/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
38.7%
48/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
General disorders
Asthenia
|
26.0%
32/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
29.0%
36/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
General disorders
Mucosal inflammation
|
18.7%
23/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
30.6%
38/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
General disorders
Chest pain
|
9.8%
12/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
2.4%
3/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
General disorders
Pyrexia
|
3.3%
4/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
7.3%
9/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
General disorders
Oedema peripheral
|
4.1%
5/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
5.6%
7/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
General disorders
General physical health deterioration
|
1.6%
2/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
6.5%
8/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Infections and infestations
Urinary tract infection
|
7.3%
9/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
12.1%
15/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.5%
8/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
8.9%
11/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Investigations
Weight decreased
|
30.9%
38/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
52.4%
65/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Investigations
Aspartate aminotransferase increased
|
28.5%
35/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
30.6%
38/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Investigations
Alanine aminotransferase increased
|
29.3%
36/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
29.0%
36/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
13.0%
16/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
16.9%
21/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Investigations
Gamma-glutamyltransferase increased
|
12.2%
15/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
12.1%
15/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Investigations
Blood lactate dehydrogenase increased
|
8.9%
11/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
12.9%
16/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Investigations
Blood alkaline phosphatase increased
|
10.6%
13/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
9.7%
12/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Investigations
Lipase increased
|
10.6%
13/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
7.3%
9/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Investigations
Amylase increased
|
9.8%
12/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
6.5%
8/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Investigations
Blood bilirubin increased
|
6.5%
8/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
7.3%
9/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Investigations
White blood cell count decreased
|
4.9%
6/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
6.5%
8/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Investigations
Neutrophil count decreased
|
1.6%
2/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
5.6%
7/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
35.8%
44/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
37.1%
46/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
25.2%
31/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
28.2%
35/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
13.0%
16/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
24.2%
30/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.3%
9/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
16.9%
21/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
5.6%
7/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.0%
16/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
11.3%
14/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.8%
17/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
8.9%
11/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.9%
11/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
10.5%
13/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.9%
6/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
7.3%
9/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.9%
11/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
3.2%
4/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.5%
8/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
2.4%
3/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.7%
7/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
3.2%
4/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.7%
7/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
1.6%
2/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Nervous system disorders
Dysgeusia
|
22.0%
27/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
18.5%
23/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Nervous system disorders
Headache
|
18.7%
23/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
14.5%
18/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Nervous system disorders
Dizziness
|
9.8%
12/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
11.3%
14/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Nervous system disorders
Paraesthesia
|
7.3%
9/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
4.8%
6/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Psychiatric disorders
Insomnia
|
9.8%
12/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
8.1%
10/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Renal and urinary disorders
Proteinuria
|
14.6%
18/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
16.1%
20/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
13.8%
17/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
13.7%
17/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.8%
12/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
8.1%
10/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.5%
8/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
8.9%
11/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.3%
9/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
7.3%
9/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.9%
11/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
4.8%
6/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
5.7%
7/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
3.2%
4/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
54.5%
67/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
53.2%
66/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
17.9%
22/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
19.4%
24/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.9%
11/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
17.7%
22/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.9%
6/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
18.5%
23/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.9%
6/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
8.9%
11/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
|
Vascular disorders
Hypertension
|
20.3%
25/123 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
33.9%
42/124 • From first dose to 30 days following last dose (up to a maximum of 61 months)
Measured in the Safety Population, which included participants who received any amount of study drug. Per prespecified analysis, all participants who died during the study met the study requirements of study completion.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place