Trial Outcomes & Findings for Mobile Devices to Detect Early Pneumonitis in Stage III NSCLC Patients on Durvalumab. (NCT NCT04381494)
NCT ID: NCT04381494
Last Updated: 2023-06-22
Results Overview
An AE was occurrence of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product or device, whether or not considered causally related to the product or device medical occurrence in a participant. The TEAEs of pneumonitis were defined as any pneumonitis event that occurred or worsened at any time after the start of administration of the first dose of durvalumab and through 30 days after the last dose of durvalumab. Severity (intensity of any event) was assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse events (CTCAE) v5. The AEs were assigned to a Grade from 1 through 5 as follows: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life-threatening requiring hospitalization; Grade 4: Life-threatening consequences; Grade 5: Death due to any AE.
TERMINATED
PHASE4
40 participants
TEAEs were reported from the first dose of durvalumab up to 30 days after the last dose of durvalumab, a maximum of approximately 13 months
2023-06-22
Participant Flow
This was a prospective, interventional pilot study of mobile devices and digital applications conducted at 25 sites in the United States to detect early signs of pneumonitis and other pulmonary adverse events (AEs) in participants with unresectable Stage III Non-Small Cell Lung Cancer (NSCLC) whose disease had not progressed following 2 or more cycles of concurrent chemoradiotherapy, treated with durvalumab.
A total of 40 participants were enrolled in this study after their treating physician prescribed durvalumab and before starting durvalumab. Data was collected via Current Wearable Health Monitoring System.
Participant milestones
| Measure |
All Participants
Participants were trained on the mobile applications and received mobile and wearable devices alongside their durvalumab treatment without any additional interventions. Participants received durvalumab for up to 12 months or until confirmed disease progression, permanent discontinuation of durvalumab, the initiation of alternative cancer therapy, unacceptable toxic events, death, or withdrawal of consent, whichever was sooner.
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|---|---|
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Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
35
|
Reasons for withdrawal
| Measure |
All Participants
Participants were trained on the mobile applications and received mobile and wearable devices alongside their durvalumab treatment without any additional interventions. Participants received durvalumab for up to 12 months or until confirmed disease progression, permanent discontinuation of durvalumab, the initiation of alternative cancer therapy, unacceptable toxic events, death, or withdrawal of consent, whichever was sooner.
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|---|---|
|
Overall Study
Early termination of trial
|
19
|
|
Overall Study
Investigator's discretion
|
1
|
|
Overall Study
Withdrawal by Subject
|
9
|
|
Overall Study
NSCLC disease progression
|
4
|
|
Overall Study
Device-Related Adverse Event
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Participants
n=40 Participants
Participants were trained on the mobile applications and received mobile and wearable devices alongside their durvalumab treatment without any additional interventions. Participants received durvalumab for up to 12 months or until confirmed disease progression, permanent discontinuation of durvalumab, the initiation of alternative cancer therapy, unacceptable toxic events, death, or withdrawal of consent, whichever was sooner.
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|---|---|
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Age, Continuous
|
65.1 years
STANDARD_DEVIATION 8.92 • n=40 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: TEAEs were reported from the first dose of durvalumab up to 30 days after the last dose of durvalumab, a maximum of approximately 13 monthsPopulation: The SAF included all enrolled participants who took at least 1 dose of durvalumab.
An AE was occurrence of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product or device, whether or not considered causally related to the product or device medical occurrence in a participant. The TEAEs of pneumonitis were defined as any pneumonitis event that occurred or worsened at any time after the start of administration of the first dose of durvalumab and through 30 days after the last dose of durvalumab. Severity (intensity of any event) was assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse events (CTCAE) v5. The AEs were assigned to a Grade from 1 through 5 as follows: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life-threatening requiring hospitalization; Grade 4: Life-threatening consequences; Grade 5: Death due to any AE.
Outcome measures
| Measure |
All Participants
n=40 Participants
Participants were trained on the mobile applications and received mobile and wearable devices alongside their durvalumab treatment without any additional interventions. Participants received durvalumab for up to 12 months or until confirmed disease progression, permanent discontinuation of durvalumab, the initiation of alternative cancer therapy, unacceptable toxic events, death, or withdrawal of consent, whichever was sooner.
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|---|---|
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Number of Participants With Treatment-Emergent Adverse Event (TEAE) of Pneumonitis by Grade
Grade 2
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2 Participants
|
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Number of Participants With Treatment-Emergent Adverse Event (TEAE) of Pneumonitis by Grade
Grade 3
|
1 Participants
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SECONDARY outcome
Timeframe: TEAEs were reported from the first dose of durvalumab up to 30 days after the last dose of durvalumab, a maximum of approximately 13 monthsPopulation: The SAF included all enrolled participants who took at least 1 dose of durvalumab.
Pulmonary TEAEs were defined as any pulmonary AEs that occurred or worsened at any time after the start of administration of the first dose of durvalumab and through 30 days after the last dose of durvalumab. Number of participants with permanent discontinuation of durvalumab due to pulmonary TEAEs including pneumonitis are reported.
Outcome measures
| Measure |
All Participants
n=40 Participants
Participants were trained on the mobile applications and received mobile and wearable devices alongside their durvalumab treatment without any additional interventions. Participants received durvalumab for up to 12 months or until confirmed disease progression, permanent discontinuation of durvalumab, the initiation of alternative cancer therapy, unacceptable toxic events, death, or withdrawal of consent, whichever was sooner.
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|---|---|
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Number of Participants With Permanent Discontinuation of Durvalumab Due to Pulmonary TEAEs
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0 Participants
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SECONDARY outcome
Timeframe: Up to Month 12Population: The SAF included all enrolled participants who took at least 1 dose of durvalumab.
The overall duration of durvalumab treatment, while participants were a part of this wearable study, was calculated as end date of durvalumab treatment minus first dose of durvalumab (Day 1) plus 1.
Outcome measures
| Measure |
All Participants
n=40 Participants
Participants were trained on the mobile applications and received mobile and wearable devices alongside their durvalumab treatment without any additional interventions. Participants received durvalumab for up to 12 months or until confirmed disease progression, permanent discontinuation of durvalumab, the initiation of alternative cancer therapy, unacceptable toxic events, death, or withdrawal of consent, whichever was sooner.
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|---|---|
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Duration of Durvalumab Treatment
|
107.5 days
Interval 1.0 to 352.0
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SECONDARY outcome
Timeframe: Up to Month 12Population: The SAF included all enrolled participants who took at least 1 dose of durvalumab.
Number of participants who discontinued durvalumab early due to any reason are reported.
Outcome measures
| Measure |
All Participants
n=40 Participants
Participants were trained on the mobile applications and received mobile and wearable devices alongside their durvalumab treatment without any additional interventions. Participants received durvalumab for up to 12 months or until confirmed disease progression, permanent discontinuation of durvalumab, the initiation of alternative cancer therapy, unacceptable toxic events, death, or withdrawal of consent, whichever was sooner.
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|---|---|
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Number of Participants With Early Discontinuation of Durvalumab
|
3 Participants
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SECONDARY outcome
Timeframe: Up to Month 12Population: The SAF included all enrolled participants who took at least 1 dose of durvalumab.
Treatment interruptions were defined as at least 1 temporary withholding of durvalumab treatment. Treatment withheld was defined as temporarily withheld of durvalumab recorded in case report form. Short interruptions defined as the durvalumab infusion interruption during the administration recorded in CRF in a single visit were excluded from the analysis. Due to data issue, the reason for treatment withheld was not captured in the database.
Outcome measures
| Measure |
All Participants
n=40 Participants
Participants were trained on the mobile applications and received mobile and wearable devices alongside their durvalumab treatment without any additional interventions. Participants received durvalumab for up to 12 months or until confirmed disease progression, permanent discontinuation of durvalumab, the initiation of alternative cancer therapy, unacceptable toxic events, death, or withdrawal of consent, whichever was sooner.
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|---|---|
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Number of Participants With Treatment Interruptions
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9 Participants
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SECONDARY outcome
Timeframe: Up to Month 12Population: The SAF included all enrolled participants who took at least 1 dose of durvalumab.
The overall duration of durvalumab treatment interruption was calculated as the sum of the duration of each treatment withheld/resumed. The duration of interruption included only treatment withheld. Short interruption which resumed during the same visit was not included in the calculation for duration of interruption.
Outcome measures
| Measure |
All Participants
n=40 Participants
Participants were trained on the mobile applications and received mobile and wearable devices alongside their durvalumab treatment without any additional interventions. Participants received durvalumab for up to 12 months or until confirmed disease progression, permanent discontinuation of durvalumab, the initiation of alternative cancer therapy, unacceptable toxic events, death, or withdrawal of consent, whichever was sooner.
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|---|---|
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Duration of Durvalumab Treatment Interruption
|
50.8 days
Standard Deviation 50.79
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SECONDARY outcome
Timeframe: TEAEs were reported from the first dose of durvalumab up to 30 days after the last dose of durvalumab, a maximum of approximately 13 monthsPopulation: The SAF included all enrolled participants who took at least 1 dose of durvalumab.
Pulmonary TEAEs were defined as any pulmonary AEs that occurred or worsened at any time after the start of administration of the first dose of durvalumab and through 30 days after the last dose of durvalumab.
Outcome measures
| Measure |
All Participants
n=40 Participants
Participants were trained on the mobile applications and received mobile and wearable devices alongside their durvalumab treatment without any additional interventions. Participants received durvalumab for up to 12 months or until confirmed disease progression, permanent discontinuation of durvalumab, the initiation of alternative cancer therapy, unacceptable toxic events, death, or withdrawal of consent, whichever was sooner.
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|---|---|
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Number of Participants With Pulmonary TEAEs Excluding Pneumonitis
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19 Participants
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SECONDARY outcome
Timeframe: TEAEs were reported from the first dose of durvalumab up to 30 days after the last dose of durvalumab, a maximum of approximately 13 monthsPopulation: The SAF included all enrolled participants who took at least 1 dose of durvalumab. Only those participants with pulmonary TEAEs excluding pneumonitis were included in this analysis.
Pulmonary TEAEs were defined as any pulmonary AEs that occurred or worsened at any time after the start of administration of the first dose of durvalumab and through 30 days after the last dose of durvalumab. Duration of pulmonary TEAEs was calculated as end date of pulmonary TEAE minus onset date of pulmonary TEAE plus 1. For AEs that were missing an end date, the data cut-off date was used as the AE end date for calculation of AE duration.
Outcome measures
| Measure |
All Participants
n=19 Participants
Participants were trained on the mobile applications and received mobile and wearable devices alongside their durvalumab treatment without any additional interventions. Participants received durvalumab for up to 12 months or until confirmed disease progression, permanent discontinuation of durvalumab, the initiation of alternative cancer therapy, unacceptable toxic events, death, or withdrawal of consent, whichever was sooner.
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|---|---|
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Duration of Pulmonary TEAEs Excluding Pneumonitis
|
153.4 days
Standard Deviation 156.26
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SECONDARY outcome
Timeframe: Up to Month 12Population: The SAF included all enrolled participants who took at least 1 dose of durvalumab. Only those participants with pneumonitis TEAEs were analyzed.
Pneumonitis TEAEs were defined as any pneumonitis AEs that occurred or worsened at any time after the start of administration of the first dose of durvalumab and through 30 days after the last dose of durvalumab.
Outcome measures
| Measure |
All Participants
n=3 Participants
Participants were trained on the mobile applications and received mobile and wearable devices alongside their durvalumab treatment without any additional interventions. Participants received durvalumab for up to 12 months or until confirmed disease progression, permanent discontinuation of durvalumab, the initiation of alternative cancer therapy, unacceptable toxic events, death, or withdrawal of consent, whichever was sooner.
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|---|---|
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Number of Participants Who Received Prescription Medication to Manage Pneumonitis TEAEs
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2 Participants
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SECONDARY outcome
Timeframe: Up to Month 12Population: The SAF included all enrolled participants who took at least 1 dose of durvalumab. Only those participants with pneumonitis TEAEs were analyzed.
Pneumonitis TEAEs were defined as any pneumonitis AEs that occurred or worsened at any time after the start of administration of the first dose of durvalumab and through 30 days after the last dose of durvalumab.
Outcome measures
| Measure |
All Participants
n=2 Participants
Participants were trained on the mobile applications and received mobile and wearable devices alongside their durvalumab treatment without any additional interventions. Participants received durvalumab for up to 12 months or until confirmed disease progression, permanent discontinuation of durvalumab, the initiation of alternative cancer therapy, unacceptable toxic events, death, or withdrawal of consent, whichever was sooner.
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|---|---|
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Duration of Prescription Medication Received by Participants to Manage Pneumonitis TEAEs
|
17.5 days
Standard Deviation 3.54
|
SECONDARY outcome
Timeframe: TEAEs were reported from the first dose of durvalumab up to 30 days after the last dose of durvalumab, a maximum of approximately 13 monthsPopulation: Data was not collected due to early termination of the trial.
Duration of development of Grade 3 to 5 pneumonitis AEs is defined as the period from Day 1 to earliest of each grade of pneumonitis AE (grade 3, grade 4, and grade 5). Severity (intensity of an event) was assessed using the NCI-CTCAE v5. AEs were assigned to a Grade from 1 through 5 as follows: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life-threatening requiring hospitalization; Grade 4: Life-threatening consequences; Grade 5: Death due to any AE.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline visit (Day 1), every 2 weeks for the first 3 months and once monthly thereafter, and at End-of-Study visit (Month 12)Population: The SAF included all enrolled participants who took at least 1 dose of durvalumab. For each symptom scale, only those participants with data available were included in the analysis.
The EORTC QLQ-C30 consisted of 30 questions and included functional scales (FS) (items 1-7 and items 20-27), symptom scales (items 8-19 and item 28) and global measure of health status (GHS) (items 29-30). The scale ranged from 1-4 for most outcome measures of systems, with 1 rated as "not at all" and 4 rated as "very much". Scores were averaged and transformed to 0 to 100, a high score for functional scales/GHS represented better functioning ability/QoL, whereas a high score for symptom scales represented stronger symptoms/worse QoL. Participants with pneumonitis TEAEs with causal relationship with durvalumab are presented. Time point 1: prior to occurrence of initial pneumonitis AE; Time point 2: at same time point as initial pneumonitis AE; Time point 3: when highest CTCAE grade of pneumonitis AE occurred. Baseline was defined as the date of informed consent for this parameter.
Outcome measures
| Measure |
All Participants
n=40 Participants
Participants were trained on the mobile applications and received mobile and wearable devices alongside their durvalumab treatment without any additional interventions. Participants received durvalumab for up to 12 months or until confirmed disease progression, permanent discontinuation of durvalumab, the initiation of alternative cancer therapy, unacceptable toxic events, death, or withdrawal of consent, whichever was sooner.
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|---|---|
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Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 Items (EORTC QLQ-C30) in Participants With Pneumonitis TEAEs
FS; Time point 1
|
5.56 scores on a scale
Standard Deviation 4.714
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Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 Items (EORTC QLQ-C30) in Participants With Pneumonitis TEAEs
FS; Time point 2
|
2.22 scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 Items (EORTC QLQ-C30) in Participants With Pneumonitis TEAEs
FS; Time point 3
|
2.22 scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
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|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 Items (EORTC QLQ-C30) in Participants With Pneumonitis TEAEs
Symptom scale; Time point 1
|
-10.26 scores on a scale
Standard Deviation 3.626
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 Items (EORTC QLQ-C30) in Participants With Pneumonitis TEAEs
Symptom scale; Time point 2
|
-7.69 scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 Items (EORTC QLQ-C30) in Participants With Pneumonitis TEAEs
Symptom scale; Time point 3
|
-7.69 scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
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|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 Items (EORTC QLQ-C30) in Participants With Pneumonitis TEAEs
GHS; Time point 1
|
4.17 scores on a scale
Standard Deviation 5.893
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 Items (EORTC QLQ-C30) in Participants With Pneumonitis TEAEs
GHS; Time point 2
|
8.33 scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 Items (EORTC QLQ-C30) in Participants With Pneumonitis TEAEs
GHS; Time point 3
|
8.33 scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
SECONDARY outcome
Timeframe: Baseline visit (Day 1), every 2 weeks for the first 3 months and once monthly thereafter, and at End-of-Study visit (Month 12)Population: The SAF included all enrolled participants who took at least 1 dose of durvalumab. For each symptom scale, only those participants with data available were included in the analysis.
The EORTC QLQ-LC13 was a disease-specific 13-item questionnaire for lung cancer used in conjunction with the EORTC QLQ-C30. It comprised both multi-item and single-item measures of lung cancer associated symptoms (LCAS) (items 31-35 and items 40-42), treatment related side effects (TREF) (items 36-39) and pain medication (item 43). The scale ranged from 1-4 for most outcome measures of systems, 1 rated as "not at all" and 4 rated as "very much". Scores were averaged and transformed to 0 to 100, higher scores for LCAS and TREF: greater level of symptoms/worse QoL and higher scores for pain medication: better pain relief from medication. Participants with pneumonitis TEAEs with causal relationship with durvalumab are presented. Time point 1: prior to occurrence of initial pneumonitis AE; Time point 2: at same time point as initial pneumonitis AE; Time point 3: when highest CTCAE grade of pneumonitis AE occurred. Baseline was defined as the date of informed consent for this parameter.
Outcome measures
| Measure |
All Participants
n=40 Participants
Participants were trained on the mobile applications and received mobile and wearable devices alongside their durvalumab treatment without any additional interventions. Participants received durvalumab for up to 12 months or until confirmed disease progression, permanent discontinuation of durvalumab, the initiation of alternative cancer therapy, unacceptable toxic events, death, or withdrawal of consent, whichever was sooner.
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|---|---|
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Change From Baseline in EORTC QLQ-Lung Cancer (LC)13 in Participants With Pneumonitis TEAEs
LCAS; Time point 1
|
-4.17 scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
|
Change From Baseline in EORTC QLQ-Lung Cancer (LC)13 in Participants With Pneumonitis TEAEs
TREF; Time point 1
|
-8.33 scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
|
Change From Baseline in EORTC QLQ-Lung Cancer (LC)13 in Participants With Pneumonitis TEAEs
Pain medication; Time point 1
|
0 scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
Adverse Events
All Participants
Serious adverse events
| Measure |
All Participants
n=40 participants at risk
Participants were trained on the mobile applications and received mobile and wearable devices alongside their durvalumab treatment without any additional interventions. Participants received durvalumab for up to 12 months or until confirmed disease progression, permanent discontinuation of durvalumab, the initiation of alternative cancer therapy, unacceptable toxic events, death, or withdrawal of consent, whichever was sooner.
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|---|---|
|
Gastrointestinal disorders
Nausea
|
2.5%
1/40 • Number of events 1 • TEAEs were reported from the first dose of durvalumab up to 30 days after the last dose of durvalumab, a maximum of approximately 13 months
The SAF included all enrolled participants who took at least 1 dose of durvalumab.
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
1/40 • Number of events 1 • TEAEs were reported from the first dose of durvalumab up to 30 days after the last dose of durvalumab, a maximum of approximately 13 months
The SAF included all enrolled participants who took at least 1 dose of durvalumab.
|
|
General disorders
Disease progression
|
2.5%
1/40 • Number of events 1 • TEAEs were reported from the first dose of durvalumab up to 30 days after the last dose of durvalumab, a maximum of approximately 13 months
The SAF included all enrolled participants who took at least 1 dose of durvalumab.
|
|
Infections and infestations
Pneumonia
|
5.0%
2/40 • Number of events 2 • TEAEs were reported from the first dose of durvalumab up to 30 days after the last dose of durvalumab, a maximum of approximately 13 months
The SAF included all enrolled participants who took at least 1 dose of durvalumab.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.5%
1/40 • Number of events 1 • TEAEs were reported from the first dose of durvalumab up to 30 days after the last dose of durvalumab, a maximum of approximately 13 months
The SAF included all enrolled participants who took at least 1 dose of durvalumab.
|
|
Nervous system disorders
Dizziness
|
2.5%
1/40 • Number of events 1 • TEAEs were reported from the first dose of durvalumab up to 30 days after the last dose of durvalumab, a maximum of approximately 13 months
The SAF included all enrolled participants who took at least 1 dose of durvalumab.
|
|
Nervous system disorders
Headache
|
2.5%
1/40 • Number of events 1 • TEAEs were reported from the first dose of durvalumab up to 30 days after the last dose of durvalumab, a maximum of approximately 13 months
The SAF included all enrolled participants who took at least 1 dose of durvalumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.5%
1/40 • Number of events 1 • TEAEs were reported from the first dose of durvalumab up to 30 days after the last dose of durvalumab, a maximum of approximately 13 months
The SAF included all enrolled participants who took at least 1 dose of durvalumab.
|
Other adverse events
| Measure |
All Participants
n=40 participants at risk
Participants were trained on the mobile applications and received mobile and wearable devices alongside their durvalumab treatment without any additional interventions. Participants received durvalumab for up to 12 months or until confirmed disease progression, permanent discontinuation of durvalumab, the initiation of alternative cancer therapy, unacceptable toxic events, death, or withdrawal of consent, whichever was sooner.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
5/40 • Number of events 5 • TEAEs were reported from the first dose of durvalumab up to 30 days after the last dose of durvalumab, a maximum of approximately 13 months
The SAF included all enrolled participants who took at least 1 dose of durvalumab.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
4/40 • Number of events 6 • TEAEs were reported from the first dose of durvalumab up to 30 days after the last dose of durvalumab, a maximum of approximately 13 months
The SAF included all enrolled participants who took at least 1 dose of durvalumab.
|
|
General disorders
Fatigue
|
17.5%
7/40 • Number of events 8 • TEAEs were reported from the first dose of durvalumab up to 30 days after the last dose of durvalumab, a maximum of approximately 13 months
The SAF included all enrolled participants who took at least 1 dose of durvalumab.
|
|
General disorders
Non-cardiac chest pain
|
10.0%
4/40 • Number of events 4 • TEAEs were reported from the first dose of durvalumab up to 30 days after the last dose of durvalumab, a maximum of approximately 13 months
The SAF included all enrolled participants who took at least 1 dose of durvalumab.
|
|
General disorders
Pyrexia
|
12.5%
5/40 • Number of events 5 • TEAEs were reported from the first dose of durvalumab up to 30 days after the last dose of durvalumab, a maximum of approximately 13 months
The SAF included all enrolled participants who took at least 1 dose of durvalumab.
|
|
Cardiac disorders
Tachycardia
|
10.0%
4/40 • Number of events 4 • TEAEs were reported from the first dose of durvalumab up to 30 days after the last dose of durvalumab, a maximum of approximately 13 months
The SAF included all enrolled participants who took at least 1 dose of durvalumab.
|
|
Nervous system disorders
Dizziness
|
10.0%
4/40 • Number of events 6 • TEAEs were reported from the first dose of durvalumab up to 30 days after the last dose of durvalumab, a maximum of approximately 13 months
The SAF included all enrolled participants who took at least 1 dose of durvalumab.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.5%
3/40 • Number of events 3 • TEAEs were reported from the first dose of durvalumab up to 30 days after the last dose of durvalumab, a maximum of approximately 13 months
The SAF included all enrolled participants who took at least 1 dose of durvalumab.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
8/40 • Number of events 8 • TEAEs were reported from the first dose of durvalumab up to 30 days after the last dose of durvalumab, a maximum of approximately 13 months
The SAF included all enrolled participants who took at least 1 dose of durvalumab.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.0%
8/40 • Number of events 8 • TEAEs were reported from the first dose of durvalumab up to 30 days after the last dose of durvalumab, a maximum of approximately 13 months
The SAF included all enrolled participants who took at least 1 dose of durvalumab.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.5%
3/40 • Number of events 3 • TEAEs were reported from the first dose of durvalumab up to 30 days after the last dose of durvalumab, a maximum of approximately 13 months
The SAF included all enrolled participants who took at least 1 dose of durvalumab.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.5%
3/40 • Number of events 4 • TEAEs were reported from the first dose of durvalumab up to 30 days after the last dose of durvalumab, a maximum of approximately 13 months
The SAF included all enrolled participants who took at least 1 dose of durvalumab.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place