Trial Outcomes & Findings for CS-7017 in Combination With Erlotinib in Subjects With Stage IIIb/IV Non-small Cell Lung Cancer (NSCLC) (NCT NCT01199068)
NCT ID: NCT01199068
Last Updated: 2021-05-13
Results Overview
A treatment-emergent adverse event (TEAE) is defined as any event not present prior to the initiation of the drug treatment or any event already present that worsens in either intensity or frequency following exposure to the drug treatment. A CS-7017-related TEAE is an TEAE that is related to CS7017 in the relationship.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
From post first dose to 30 days after last dose, up to approximately 1.5 years
Results posted on
2021-05-13
Participant Flow
A total of 15 participants who met all inclusion and no exclusion criteria were enrolled in the study. Fourteen participants received treatment.
This study consisted of 2 parts: initial portion and additional portion. In the initial portion, participants received CS-7017 (starting dose 0.25 mg BID ascending to 0.50 mg BID) in combination with erlotinib. In the additional portion, participants received CS-7017 0.50 mg BID in combination with erlotinib.
Participant milestones
| Measure |
CS-7017 0.25 mg BID; Initial Portion
Participants who received oral CS-7017 0.25 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
|
CS-7017 0.50 mg BID; Initial Portion
Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
|
CS-7017 0.50 mg BID; Additional Portion
Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
9
|
|
Overall Study
Received Treatment
|
3
|
3
|
8
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
9
|
Reasons for withdrawal
| Measure |
CS-7017 0.25 mg BID; Initial Portion
Participants who received oral CS-7017 0.25 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
|
CS-7017 0.50 mg BID; Initial Portion
Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
|
CS-7017 0.50 mg BID; Additional Portion
Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
|
|---|---|---|---|
|
Overall Study
Unacceptable toxicity
|
0
|
0
|
2
|
|
Overall Study
Progressive disease
|
3
|
3
|
6
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
Baseline Characteristics
CS-7017 in Combination With Erlotinib in Subjects With Stage IIIb/IV Non-small Cell Lung Cancer (NSCLC)
Baseline characteristics by cohort
| Measure |
CS-7017 0.25 mg BID; Initial Portion
n=3 Participants
Participants who received oral CS-7017 0.25 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
|
CS-7017 0.50 mg BID; Initial Portion
n=3 Participants
Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
|
CS-7017 0.50 mg BID; Additional Portion
n=8 Participants
Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
|
Total
n=14 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Continuous
|
54.3 years
STANDARD_DEVIATION 8.39 • n=5 Participants
|
53.3 years
STANDARD_DEVIATION 4.04 • n=7 Participants
|
60.0 years
STANDARD_DEVIATION 9.89 • n=5 Participants
|
57.4 years
STANDARD_DEVIATION 8.72 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Region of Enrollment
South Korea
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
14 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From post first dose to 30 days after last dose, up to approximately 1.5 yearsPopulation: CS-7017-related TEAEs were assessed in the Safety Analysis Set.
A treatment-emergent adverse event (TEAE) is defined as any event not present prior to the initiation of the drug treatment or any event already present that worsens in either intensity or frequency following exposure to the drug treatment. A CS-7017-related TEAE is an TEAE that is related to CS7017 in the relationship.
Outcome measures
| Measure |
CS-7017 0.25 mg BID; Initial Portion
n=3 Participants
Participants who received oral CS-7017 0.25 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
|
CS-7017 0.50 mg BID; Initial Portion
n=3 Participants
Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
|
CS-7017 0.50 mg BID; Additional Portion
n=8 Participants
Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
|
CS-7017 0.50 mg BID; Initial + Additional Portions
n=11 Participants
Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily (combined initial and additional portions).
|
Overall
n=14 Participants
All participants who received CS-71017 in combination with erlotinib.
|
|---|---|---|---|---|---|
|
CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Investigations
|
1 Participants
|
1 Participants
|
7 Participants
|
8 Participants
|
9 Participants
|
|
CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
At least one CS-7017-Relaed TEAE
|
2 Participants
|
2 Participants
|
8 Participants
|
10 Participants
|
12 Participants
|
|
CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Blood and Lymphatic System Disorders
|
1 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
6 Participants
|
|
CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Anaemia
|
0 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
|
CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Thrombocytopenia
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Neutropenia
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Metabolism and Nutrition Disorders
|
0 Participants
|
0 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
|
CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Decreased appetite
|
0 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
|
CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Hypokalaemia
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Hyponatraemia
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Eye Disorders
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Conjunctival hyperaemia
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Cardiac Disorders
|
0 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
|
CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Pericardial effusion
|
0 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
|
CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Sinus arrhythmia
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Respiratory, Thoracic, and Mediastinal Disorders
|
0 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
|
CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Pleural effusion
|
0 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
|
CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Gastrointestinal Disorders
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Nausea
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Renal and Urinary Disorders
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Azotaemia
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Congenital, Familial, and Genetic Disorders
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Hydrocele
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
General Disorders & Administration Site Conditions
|
2 Participants
|
1 Participants
|
8 Participants
|
9 Participants
|
11 Participants
|
|
CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Face oedema
|
2 Participants
|
1 Participants
|
8 Participants
|
9 Participants
|
11 Participants
|
|
CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Oedema peripheral
|
1 Participants
|
1 Participants
|
5 Participants
|
6 Participants
|
7 Participants
|
|
CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Fatigue
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Generalised oedema
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Malaise
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Weight increased
|
1 Participants
|
1 Participants
|
7 Participants
|
8 Participants
|
9 Participants
|
|
CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Blood creatinine increased
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Blood creatinine phosphokinase increased
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Brain natriuretic peptide increased
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Electrocardiogram QT prolonged
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Cycle 1, Week 1 and Cycle 2, Week 4Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
After the first CS-7017 administration, area under the concentration-time curve from zero to the last quantifiable concentration (AUClast) and area under the concentration-time curve during dosing interval (AUCtau) were assessed.
Outcome measures
| Measure |
CS-7017 0.25 mg BID; Initial Portion
n=3 Participants
Participants who received oral CS-7017 0.25 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
|
CS-7017 0.50 mg BID; Initial Portion
n=11 Participants
Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
|
CS-7017 0.50 mg BID; Additional Portion
Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
|
CS-7017 0.50 mg BID; Initial + Additional Portions
Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily (combined initial and additional portions).
|
Overall
All participants who received CS-71017 in combination with erlotinib.
|
|---|---|---|---|---|---|
|
Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Serum Free Form of CS-7017 (R-150033) After CS-7017 and Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer
Cycle 1, Week 1: AUClast
|
50.8 ng*h/mL
Standard Deviation 38.6
|
148 ng*h/mL
Standard Deviation 84.3
|
—
|
—
|
—
|
|
Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Serum Free Form of CS-7017 (R-150033) After CS-7017 and Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer
Cycle 1, Week 1: AUCtau
|
97.2 ng*h/mL
Standard Deviation 45.8
|
205 ng*h/mL
Standard Deviation 115
|
—
|
—
|
—
|
|
Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Serum Free Form of CS-7017 (R-150033) After CS-7017 and Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer
Cycle 2, Week 4: AUClast
|
124 ng*h/mL
Standard Deviation 22.8
|
212 ng*h/mL
Standard Deviation 104
|
—
|
—
|
—
|
|
Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Serum Free Form of CS-7017 (R-150033) After CS-7017 and Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer
Cycle 2, Week 4: AUCtau
|
174 ng*h/mL
Standard Deviation 27.0
|
307 ng*h/mL
Standard Deviation 156
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 1, Week 1 and Cycle 2, Week 4Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
After the first CS-7017 administration, observed serum concentration (Cmax) and observed serum concentration at steady state (Cmax,ss) were assessed.
Outcome measures
| Measure |
CS-7017 0.25 mg BID; Initial Portion
n=3 Participants
Participants who received oral CS-7017 0.25 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
|
CS-7017 0.50 mg BID; Initial Portion
n=11 Participants
Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
|
CS-7017 0.50 mg BID; Additional Portion
Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
|
CS-7017 0.50 mg BID; Initial + Additional Portions
Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily (combined initial and additional portions).
|
Overall
All participants who received CS-71017 in combination with erlotinib.
|
|---|---|---|---|---|---|
|
Pharmacokinetic Parameter Observed Serum Concentration (Cmax) of Serum Free Form of CS-7017 (R-150033) After CS-7017 and Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer
Cycle 1, Week 1: Cmax
|
9.98 ng/mL
Standard Deviation 6.20
|
25.1 ng/mL
Standard Deviation 14.0
|
—
|
—
|
—
|
|
Pharmacokinetic Parameter Observed Serum Concentration (Cmax) of Serum Free Form of CS-7017 (R-150033) After CS-7017 and Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer
Cycle 2, Week 4: Cmax,ss
|
18.9 ng/mL
Standard Deviation 3.75
|
32.4 ng/mL
Standard Deviation 16.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 1, Week 1 and Cycle 2, Week 4Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
After the first CS-7017 administration, time of maximum plasma concentration (Tmax) and time of maximum plasma concentration at steady state (Tmax,ss) were assessed.
Outcome measures
| Measure |
CS-7017 0.25 mg BID; Initial Portion
n=3 Participants
Participants who received oral CS-7017 0.25 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
|
CS-7017 0.50 mg BID; Initial Portion
n=11 Participants
Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
|
CS-7017 0.50 mg BID; Additional Portion
Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
|
CS-7017 0.50 mg BID; Initial + Additional Portions
Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily (combined initial and additional portions).
|
Overall
All participants who received CS-71017 in combination with erlotinib.
|
|---|---|---|---|---|---|
|
Pharmacokinetic Parameter Time of Maximum Plasma Concentration (Tmax) of Serum Free Form of CS-7017 (R-150033) After CS-7017 and Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer
Cycle 1, Week 1: Tmax
|
3.00 h
Interval 2.0 to 8.0
|
3.00 h
Interval 1.95 to 4.0
|
—
|
—
|
—
|
|
Pharmacokinetic Parameter Time of Maximum Plasma Concentration (Tmax) of Serum Free Form of CS-7017 (R-150033) After CS-7017 and Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer
Cycle 2, Week 4: Tmax,ss
|
3.50 h
Interval 3.0 to 4.0
|
3.00 h
Interval 0.5 to 4.02
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From screening and after completion of every 2 cycles (6 weeks) until disease progression, withdrawal of consent, death, or loss to follow-up, up to approximately 1.5 yearsPopulation: Best overall response and response rate were assessed in the Efficacy Analysis Set.
As per Response Evaluation Criteria for Solid Tumors v1.1, best overall response was characterized as complete response (CR) defined as disappearance of all target lesions, partial response (PR) defined as ≥30% decrease in the sum of diameters of target lesions, progressive disease (PD) defined as ≥20% increase in the sum of diameters of target lesions, and stable disease (SD) defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Response rate was defined as CR + PR.
Outcome measures
| Measure |
CS-7017 0.25 mg BID; Initial Portion
n=2 Participants
Participants who received oral CS-7017 0.25 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
|
CS-7017 0.50 mg BID; Initial Portion
n=3 Participants
Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
|
CS-7017 0.50 mg BID; Additional Portion
n=7 Participants
Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
|
CS-7017 0.50 mg BID; Initial + Additional Portions
n=10 Participants
Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily (combined initial and additional portions).
|
Overall
n=12 Participants
All participants who received CS-71017 in combination with erlotinib.
|
|---|---|---|---|---|---|
|
Best Overall Response and Response Rate Following Administration of CS-7017 in Combination With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) Who Failed First-line Therapy
Partial response (PR)
|
0 Participants
|
0 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
|
Best Overall Response and Response Rate Following Administration of CS-7017 in Combination With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) Who Failed First-line Therapy
Stable disease (SD)
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
|
Best Overall Response and Response Rate Following Administration of CS-7017 in Combination With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) Who Failed First-line Therapy
Progressive disesae (PD)
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Best Overall Response and Response Rate Following Administration of CS-7017 in Combination With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) Who Failed First-line Therapy
Response rate (CR+PR)
|
0 Participants
|
0 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: From randomization to PD or death, up to approximately 1.5 yearsPopulation: Per-protocol Progression-free Survival Time data was only assessed in the 0.50 mg BID (additional portion) and the 0.5 mg BID (initial and additional portions) Groups.
Progression-free survival (PFS) was defined as the time from randomization to the date of the first objective documentation of progressive disease (PD) or death resulting from any cause, whichever came first.
Outcome measures
| Measure |
CS-7017 0.25 mg BID; Initial Portion
n=7 Participants
Participants who received oral CS-7017 0.25 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
|
CS-7017 0.50 mg BID; Initial Portion
n=10 Participants
Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
|
CS-7017 0.50 mg BID; Additional Portion
n=12 Participants
Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
|
CS-7017 0.50 mg BID; Initial + Additional Portions
Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily (combined initial and additional portions).
|
Overall
All participants who received CS-71017 in combination with erlotinib.
|
|---|---|---|---|---|---|
|
Progression-free Survival Time Following Administration of CS-7017 in Combination With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) Who Failed First-line Therapy
|
125 days
Interval 82.0 to 176.0
|
82 days
Interval 41.0 to 176.0
|
84 days
Interval 64.0 to 127.0
|
—
|
—
|
SECONDARY outcome
Timeframe: From post first dose to 30 days after last dose, up to approximately 1.5 yearsPopulation: Erlotinib-related TEAEs were assessed in the Safety Analysis Set.
A treatment-emergent adverse event (TEAE) is defined as any event not present prior to the initiation of the drug treatment or any event already present that worsens in either intensity or frequency following exposure to the drug treatment. An erlotinib-related TEAE is an TEAE that is related to erlotinib in the relationship
Outcome measures
| Measure |
CS-7017 0.25 mg BID; Initial Portion
n=3 Participants
Participants who received oral CS-7017 0.25 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
|
CS-7017 0.50 mg BID; Initial Portion
n=3 Participants
Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
|
CS-7017 0.50 mg BID; Additional Portion
n=8 Participants
Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
|
CS-7017 0.50 mg BID; Initial + Additional Portions
n=11 Participants
Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily (combined initial and additional portions).
|
Overall
n=14 Participants
All participants who received CS-71017 in combination with erlotinib.
|
|---|---|---|---|---|---|
|
Erlotinib-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
At least one erolitinib-related TEAE
|
3 Participants
|
3 Participants
|
8 Participants
|
11 Participants
|
14 Participants
|
|
Erlotinib-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Infections and Infestations
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Erlotinib-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Paronychia
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Erlotinib-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Blood and Lymphatic System Disorders
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Erlotinib-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Anaemia
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Erlotinib-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Metabolism and Nutrition Disorders
|
0 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
|
Erlotinib-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Decreased appetite
|
0 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
|
Erlotinib-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Eye Disorders
|
0 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
|
Erlotinib-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Blepharitis
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Erlotinib-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Conjunctival hyperaemia
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Erlotinib-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Dry eye
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Erlotinib-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Respiratory, Thoracic, and Mediastinal Disorders
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Erlotinib-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Nasal dryness
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Erlotinib-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Nasal inflammation
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Erlotinib-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Oropharyngeal pain
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Erlotinib-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Gastrointestinal Disorders
|
1 Participants
|
2 Participants
|
8 Participants
|
10 Participants
|
11 Participants
|
|
Erlotinib-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Diarrhoea
|
1 Participants
|
2 Participants
|
6 Participants
|
8 Participants
|
9 Participants
|
|
Erlotinib-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Nausea
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Erlotinib-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Anorectal discomfort
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Erlotinib-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Flatulence
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Erlotinib-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Stomatitis
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Erlotinib-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Skin and Subcutaneous Tissue Disorders
|
3 Participants
|
2 Participants
|
8 Participants
|
10 Participants
|
13 Participants
|
|
Erlotinib-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Skin exfoliation
|
2 Participants
|
1 Participants
|
6 Participants
|
7 Participants
|
9 Participants
|
|
Erlotinib-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Dry skin
|
2 Participants
|
1 Participants
|
5 Participants
|
6 Participants
|
8 Participants
|
|
Erlotinib-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Rash
|
0 Participants
|
0 Participants
|
7 Participants
|
7 Participants
|
7 Participants
|
|
Erlotinib-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Dermatitis acneiform
|
3 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
6 Participants
|
|
Erlotinib-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Pruritus
|
2 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
6 Participants
|
|
Erlotinib-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Alopecia
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Erlotinib-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Renal and Urinary Disorders
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Erlotinib-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Azotaemia
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Erlotinib-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
General Disorders & Administration Site Conditions
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Erlotinib-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Fatigue
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Erlotinib-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Investigations
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Erlotinib-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
Blood creatinine increased
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
Adverse Events
CS-7017 0.25 mg BID; Initial Portion
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
CS-7017 0.50 mg BID; Initial Portion
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
CS-7017 0.50 mg BID; Additional Portion
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
CS-7017 0.50 mg BID; Initial + Additional Portions
Serious events: 7 serious events
Other events: 11 other events
Deaths: 1 deaths
Overall
Serious events: 8 serious events
Other events: 14 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
CS-7017 0.25 mg BID; Initial Portion
n=3 participants at risk
Participants who received oral CS-7017 0.25 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
|
CS-7017 0.50 mg BID; Initial Portion
n=3 participants at risk
Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
|
CS-7017 0.50 mg BID; Additional Portion
n=8 participants at risk
Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
|
CS-7017 0.50 mg BID; Initial + Additional Portions
n=11 participants at risk
Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily (combined initial and additional portions).
|
Overall
n=14 participants at risk
All participants who received CS-71017 in combination with erlotinib.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Pancreatitis
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial haemorrhage
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
18.2%
2/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
14.3%
2/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
Other adverse events
| Measure |
CS-7017 0.25 mg BID; Initial Portion
n=3 participants at risk
Participants who received oral CS-7017 0.25 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
|
CS-7017 0.50 mg BID; Initial Portion
n=3 participants at risk
Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
|
CS-7017 0.50 mg BID; Additional Portion
n=8 participants at risk
Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
|
CS-7017 0.50 mg BID; Initial + Additional Portions
n=11 participants at risk
Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily (combined initial and additional portions).
|
Overall
n=14 participants at risk
All participants who received CS-71017 in combination with erlotinib.
|
|---|---|---|---|---|---|
|
Infections and infestations
Paronychia
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
14.3%
2/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
18.2%
2/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
14.3%
2/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to abdominal cavity
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
66.7%
2/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
62.5%
5/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
63.6%
7/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
57.1%
8/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
14.3%
2/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
66.7%
2/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
75.0%
6/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
72.7%
8/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
64.3%
9/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
37.5%
3/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
27.3%
3/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
21.4%
3/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
25.0%
2/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
18.2%
2/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
14.3%
2/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
50.0%
4/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
45.5%
5/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
35.7%
5/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
18.2%
2/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
14.3%
2/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Psychiatric disorders
Depressed level of consciousness
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Eye disorders
Blepharitis
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Eye disorders
Vision blurred
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
37.5%
3/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
27.3%
3/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
21.4%
3/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Cardiac disorders
Sinus arrhythmia
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
25.0%
2/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
18.2%
2/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
14.3%
2/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
37.5%
3/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
27.3%
3/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
21.4%
3/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
66.7%
2/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
62.5%
5/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
63.6%
7/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
50.0%
7/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
100.0%
3/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
50.0%
4/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
63.6%
7/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
50.0%
7/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
66.7%
2/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
27.3%
3/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
21.4%
3/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
37.5%
3/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
27.3%
3/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
21.4%
3/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
66.7%
2/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
27.3%
3/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
21.4%
3/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
25.0%
2/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
18.2%
2/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
14.3%
2/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial haemorrhage
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal inflammation
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
66.7%
2/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
75.0%
6/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
72.7%
8/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
64.3%
9/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
37.5%
3/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
36.4%
4/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
28.6%
4/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
66.7%
2/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
27.3%
3/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
28.6%
4/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
66.7%
2/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
25.0%
2/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
36.4%
4/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
28.6%
4/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
37.5%
3/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
36.4%
4/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
28.6%
4/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
25.0%
2/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
18.2%
2/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
21.4%
3/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
14.3%
2/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
66.7%
2/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
18.2%
2/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
14.3%
2/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
25.0%
2/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
18.2%
2/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
14.3%
2/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
14.3%
2/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Anal pruritus
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Gastritis atropic
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
66.7%
2/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
75.0%
6/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
63.6%
7/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
64.3%
9/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
66.7%
2/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
62.5%
5/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
54.5%
6/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
57.1%
8/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
87.5%
7/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
63.6%
7/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
50.0%
7/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
100.0%
3/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
66.7%
2/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
27.3%
3/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
42.9%
6/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
66.7%
2/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
37.5%
3/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
36.4%
4/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
42.9%
6/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
25.0%
2/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
18.2%
2/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
14.3%
2/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
100.0%
3/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
36.4%
4/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
28.6%
4/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
18.2%
2/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
21.4%
3/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
18.2%
2/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
14.3%
2/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
14.3%
2/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
18.2%
2/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
14.3%
2/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
66.7%
2/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
18.2%
2/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
14.3%
2/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Renal and urinary disorders
Dysuria
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Reproductive system and breast disorders
Scrotal swelling
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
General disorders
Face oedema
|
66.7%
2/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
100.0%
8/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
81.8%
9/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
78.6%
11/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
General disorders
Oedema peripheral
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
66.7%
2/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
62.5%
5/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
63.6%
7/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
57.1%
8/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
General disorders
Fatigue
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
37.5%
3/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
36.4%
4/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
35.7%
5/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
General disorders
Asthenia
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
25.0%
2/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
27.3%
3/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
28.6%
4/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
General disorders
Generalised oedema
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
25.0%
2/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
18.2%
2/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
14.3%
2/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
General disorders
Malaise
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
General disorders
Puncture site pain
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Investigations
Weight increased
|
66.7%
2/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
87.5%
7/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
72.7%
8/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
71.4%
10/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Investigations
Blood creatinine phosphokinase increased
|
66.7%
2/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
21.4%
3/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
25.0%
2/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
18.2%
2/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
14.3%
2/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
25.0%
2/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
18.2%
2/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
14.3%
2/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Investigations
Brain natriuretic peptide increased
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Investigations
Electrocardiogram QC prolonged
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
7.1%
1/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
33.3%
1/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
0.00%
0/3 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
12.5%
1/8 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
9.1%
1/11 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
14.3%
2/14 • Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place