Trial Outcomes & Findings for Study to Access Safety of Durvalumab in Indian Adult Patients With Locally Advanced NSCLC (NCT NCT04416633)
NCT ID: NCT04416633
Last Updated: 2024-11-08
Results Overview
The number and proportion of participants who experienced AEs, SAEs, and AESIs, including interstitial lung disease/pneumonitis-like events and on-study deaths are presented.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
100 participants
Primary outcome timeframe
Evaluation Phase (Day 1 to 141) to Follow-up Phase (90 days after End of Evaluation Visit [Day 141])
Results posted on
2024-11-08
Participant Flow
Participant milestones
| Measure |
Durvalumab
Durvalumab administered intravenously for over 60 minutes at 10 mg/kg every 2 weeks.
The treatment period for this study was 20 weeks, which corresponded to 10 doses of study drug administration.
|
|---|---|
|
Overall Study
STARTED
|
100
|
|
Overall Study
COMPLETED
|
69
|
|
Overall Study
NOT COMPLETED
|
31
|
Reasons for withdrawal
| Measure |
Durvalumab
Durvalumab administered intravenously for over 60 minutes at 10 mg/kg every 2 weeks.
The treatment period for this study was 20 weeks, which corresponded to 10 doses of study drug administration.
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Disease progression as per investigator's clinical and imaging assessment
|
17
|
|
Overall Study
AE greater than Grade 3 related to study drug
|
1
|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Withdrawal by Subject
|
6
|
Baseline Characteristics
Study to Access Safety of Durvalumab in Indian Adult Patients With Locally Advanced NSCLC
Baseline characteristics by cohort
| Measure |
Durvalumab
n=100 Participants
Durvalumab administered intravenously for over 60 minutes at 10 mg/kg every 2 weeks.
The treatment period for this study was 20 weeks, which corresponded to 10 doses of study drug administration.
|
|---|---|
|
Age, Continuous
|
62.04 Years
STANDARD_DEVIATION 10.26 • n=99 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
INDIAN
|
100 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
OTHER
|
0 Participants
n=99 Participants
|
|
Height
|
164.44 centimeters
STANDARD_DEVIATION 9.04 • n=99 Participants
|
|
Weight
|
61.12 kilograms
STANDARD_DEVIATION 11.69 • n=99 Participants
|
PRIMARY outcome
Timeframe: Evaluation Phase (Day 1 to 141) to Follow-up Phase (90 days after End of Evaluation Visit [Day 141])The number and proportion of participants who experienced AEs, SAEs, and AESIs, including interstitial lung disease/pneumonitis-like events and on-study deaths are presented.
Outcome measures
| Measure |
Safety Population
n=100 Participants
All the patients who are enrolled in the study and received at least one dose of an investigational product as an IV infusion
|
|---|---|
|
Number and Proportion of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI)
Any Adverse Event
|
74 Participants
|
|
Number and Proportion of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI)
Any Serious Adverse Event
|
21 Participants
|
|
Number and Proportion of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI)
Any Treatment Emergent Adverse Event
|
74 Participants
|
|
Number and Proportion of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI)
Any Serious Treatment Emergent Adverse Event
|
21 Participants
|
|
Number and Proportion of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI)
Treatment Emergent Adverse Event related to IMP
|
26 Participants
|
|
Number and Proportion of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI)
Treatment Emergent Adverse Event leading to IMP discontinuation
|
13 Participants
|
|
Number and Proportion of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI)
Treatment Emergent Adverse Event leading to Death
|
4 Participants
|
|
Number and Proportion of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI)
Adverse events of special interest
|
8 Participants
|
PRIMARY outcome
Timeframe: Evaluation Phase (Day 1 to 141) to Follow-up Phase (90 days after End of Evaluation Visit [Day 141])The number of events of AEs, SAEs, and AESIs, including interstitial lung disease/pneumonitis-like events and on-study deaths are presented.
Outcome measures
| Measure |
Safety Population
n=100 Participants
All the patients who are enrolled in the study and received at least one dose of an investigational product as an IV infusion
|
|---|---|
|
Number of Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI)
Treatment Emergent Adverse Event related to IMP
|
55 events
|
|
Number of Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI)
Treatment Emergent Adverse Event leading to IMP discontinuation
|
24 events
|
|
Number of Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI)
Treatment Emergent Adverse Event leading to Death
|
4 events
|
|
Number of Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI)
Adverse events of special interest
|
8 events
|
|
Number of Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI)
Any Adverse Event
|
267 events
|
|
Number of Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI)
Any Serious Adverse Event
|
27 events
|
|
Number of Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI)
Any Treatment Emergent Adverse Event
|
250 events
|
|
Number of Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI)
Any Serious Treatment Emergent Adverse Event
|
27 events
|
Adverse Events
Durvalumab
Serious events: 21 serious events
Other events: 69 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Durvalumab
n=100 participants at risk
Durvalumab administered intravenously for over 60 minutes at 10 mg/kg every 2 weeks.
The treatment period for this study was 20 weeks, which corresponded to 10 doses of study drug administration.
|
|---|---|
|
General disorders
Death
|
2.0%
2/100 • Number of events 2 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
General disorders
Fatigue
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
General disorders
Pain
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
General disorders
Pyrexia
|
2.0%
2/100 • Number of events 2 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Hepatobiliary disorders
Hepatobiliary disease
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Infections and infestations
Pneumonia
|
2.0%
2/100 • Number of events 2 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Infections and infestations
Respiratory tract infection
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Infections and infestations
Sepsis
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Infections and infestations
Urinary tract infection
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Musculoskeletal and connective tissue disorders
Autoimmune myositis
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Nervous system disorders
Seizure
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
5/100 • Number of events 5 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Vascular disorders
Hypotension
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
Other adverse events
| Measure |
Durvalumab
n=100 participants at risk
Durvalumab administered intravenously for over 60 minutes at 10 mg/kg every 2 weeks.
The treatment period for this study was 20 weeks, which corresponded to 10 doses of study drug administration.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
4.0%
4/100 • Number of events 5 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Vascular disorders
Pallor
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
5/100 • Number of events 5 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Gastrointestinal disorders
Dysphagia
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Gastrointestinal disorders
Haematemesis
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Gastrointestinal disorders
Mouth ulceration
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Gastrointestinal disorders
Nausea
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Gastrointestinal disorders
Vomiting
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
General disorders
Asthenia
|
5.0%
5/100 • Number of events 5 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
General disorders
Chest pain
|
4.0%
4/100 • Number of events 4 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
General disorders
Chills
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Blood and lymphatic system disorders
Anaemia
|
4.0%
4/100 • Number of events 4 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
General disorders
Fatigue
|
4.0%
4/100 • Number of events 4 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
General disorders
Gait disturbance
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
General disorders
Non-cardiac chest pain
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
General disorders
Oedema peripheral
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
General disorders
Pain
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
General disorders
Pyrexia
|
19.0%
19/100 • Number of events 20 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
2.0%
2/100 • Number of events 2 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Infections and infestations
Bacterial infection
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Infections and infestations
COVID-19
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Infections and infestations
Fungal infection
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Infections and infestations
Hepatitis B
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Infections and infestations
Pneumonia
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Infections and infestations
Rash pustular
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Infections and infestations
Tuberculosis
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Infections and infestations
Urinary tract infection
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Investigations
Amylase increased
|
6.0%
6/100 • Number of events 6 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Investigations
Blood thyroid stimulating hormone abnormal
|
1.0%
1/100 • Number of events 3 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Investigations
Blood uric acid increased
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Investigations
Crystal urine present
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Investigations
Lipase increased
|
4.0%
4/100 • Number of events 5 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Investigations
Weight increased
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.0%
2/100 • Number of events 3 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Cardiac disorders
Sinus bradycardia
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.0%
2/100 • Number of events 2 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.0%
1/100 • Number of events 2 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
2.0%
2/100 • Number of events 3 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Cardiac disorders
Sinus tachycardia
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Metabolism and nutrition disorders
Hypophagia
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.0%
6/100 • Number of events 7 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
2.0%
2/100 • Number of events 3 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.0%
2/100 • Number of events 3 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Ear and labyrinth disorders
Vertigo
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.0%
2/100 • Number of events 2 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Nervous system disorders
Dizziness
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Nervous system disorders
Headache
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Nervous system disorders
Neuropathy peripheral
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Nervous system disorders
Post herpetic neuralgia
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Nervous system disorders
Seizure
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Nervous system disorders
Tremor
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Psychiatric disorders
Anxiety
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Psychiatric disorders
Depressed mood
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Psychiatric disorders
Depression
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Endocrine disorders
Hyperthyroidism
|
4.0%
4/100 • Number of events 4 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Psychiatric disorders
Insomnia
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Psychiatric disorders
Stress
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Renal and urinary disorders
Proteinuria
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Reproductive system and breast disorders
Pelvic pain
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
20/100 • Number of events 26 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
2.0%
2/100 • Number of events 2 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
13.0%
13/100 • Number of events 15 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.0%
2/100 • Number of events 2 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Endocrine disorders
Hypothyroidism
|
12.0%
12/100 • Number of events 13 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.0%
2/100 • Number of events 3 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Skin and subcutaneous tissue disorders
Blister
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.0%
3/100 • Number of events 3 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.0%
3/100 • Number of events 4 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
1.0%
1/100 • Number of events 1 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
3.0%
3/100 • Number of events 4 • Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).
Adverse events were to be reported by the participant(or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Investigator shall be entitled to publish the results of, or make presentations related to, the Study, provided that any publications or presentations to be made within 2 years after completion of the Study shall require the Sponsor's prior written consent.
- Publication restrictions are in place
Restriction type: OTHER