Participants With Treatment-Emergent Adverse Events (TEAEs)
A Study to Determine the Efficacy of the Combination of Daratumumab (DARA) Plus Durvalumab (DURVA) (D2) in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM) · Source last updated 2018-10-16
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From the date of the first dose of study drug until 90 days after the last dose of durvalumab or daratumumab , whichever is later. Maximum overall time on treatment was 16 weeks for daratumumab and durvalumab
What was measured
TEAEs include AEs between the earliest of the first dose date of either study drug and 90 days after the last dose of either study drug. In addition, an AE that occurred beyond the timeframe and was assessed by the doctor as possibly related to IP was considered to be treatment-emergent. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for AEs (NCI CTCAE) version 4.03, where 1= Mild; 2= Moderate; 3= Severe; 4= Life-threatening; 5= Death related to AE. Serious AEs resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in a medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes above.
Analysis population: The safety population consisted of all participants who received at least one dose of Durvalumab (Durva) or Daratumumab (Dara).
Groups in this outcome
Daratumumab and Durvalumab
Participants received intravenous daratumumab at 16 mg/kg on the same dosing schedule (weekly, every 2 weeks, or every 4 weeks of each 28-day treatment cycle) on their last prior therapy containing daratumumab regimen. The dosing schedule for daratumumab could be adjusted during the course of the study, provided the participant had a response of stable disease or better. Participants also received IV durvalumab at 1500 mg on Day 2 of Cycle 1 and then on Day 1 of Cycles ≥ 2 of each 28-day treatment cycle. Participants could continue on study treatment until progressive disease or unacceptable toxicity.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
Daratumumab and Durvalumab
18
Reported measurements
TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Daratumumab and Durvalumab
18
Not reported
Not reported
Not reported
Not reported
TEAE Related to Durva
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Daratumumab and Durvalumab
1
Not reported
Not reported
Not reported
Not reported
TEAE Related to Dara
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Daratumumab and Durvalumab
4
Not reported
Not reported
Not reported
Not reported
TEAE Related to Durva or Dara
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Daratumumab and Durvalumab
4
Not reported
Not reported
Not reported
Not reported
TEAE with CTCAE Grade (Gr) 3-4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Daratumumab and Durvalumab
11
Not reported
Not reported
Not reported
Not reported
TEAE with CTCAE Grade 3-4 Related to Durva
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Daratumumab and Durvalumab
1
Not reported
Not reported
Not reported
Not reported
TEAE with CTCAE Grade 3-4 Related to Dara
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Daratumumab and Durvalumab
2
Not reported
Not reported
Not reported
Not reported
TEAE with CTCAE Gr 3-4 Related to Durva or Dara
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Daratumumab and Durvalumab
2
Not reported
Not reported
Not reported
Not reported
TEAE with CTCAE Grade 5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Daratumumab and Durvalumab
4
Not reported
Not reported
Not reported
Not reported
TEAE with CTCAE Grade 5 Related to Durva
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Daratumumab and Durvalumab
0
Not reported
Not reported
Not reported
Not reported
TEAE with CTCAE Grade 5 Related to Dara
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Daratumumab and Durvalumab
0
Not reported
Not reported
Not reported
Not reported
TEAE with CTCAE Gr 5 Related to Durva or Dara
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Daratumumab and Durvalumab
0
Not reported
Not reported
Not reported
Not reported
Serious AE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Daratumumab and Durvalumab
7
Not reported
Not reported
Not reported
Not reported
Serious AE Related to Durva
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Daratumumab and Durvalumab
0
Not reported
Not reported
Not reported
Not reported
Serious AE Related to Dara
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Daratumumab and Durvalumab
0
Not reported
Not reported
Not reported
Not reported
Serious AE Related to Durva or Dara
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Daratumumab and Durvalumab
0
Not reported
Not reported
Not reported
Not reported
TEAE leading to Interruption of Durva
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Daratumumab and Durvalumab
1
Not reported
Not reported
Not reported
Not reported
TEAE leading to Interruption of Dara
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Daratumumab and Durvalumab
1
Not reported
Not reported
Not reported
Not reported
TEAE leading to Interruption of Durva or Dara
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Daratumumab and Durvalumab
1
Not reported
Not reported
Not reported
Not reported
TEAE interruption of Durva-without infusion delay
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Daratumumab and Durvalumab
1
Not reported
Not reported
Not reported
Not reported
TEAE interruption of Dara-without infusion delay
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Daratumumab and Durvalumab
1
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
18
title
TEAE
categories
measurements
group Id
OG000
value
1
title
TEAE Related to Durva
categories
measurements
group Id
OG000
value
4
title
TEAE Related to Dara
categories
measurements
group Id
OG000
value
4
title
TEAE Related to Durva or Dara
categories
measurements
group Id
OG000
value
11
title
TEAE with CTCAE Grade (Gr) 3-4
categories
measurements
group Id
OG000
value
1
title
TEAE with CTCAE Grade 3-4 Related to Durva
categories
measurements
group Id
OG000
value
2
title
TEAE with CTCAE Grade 3-4 Related to Dara
categories
measurements
group Id
OG000
value
2
title
TEAE with CTCAE Gr 3-4 Related to Durva or Dara
categories
measurements
group Id
OG000
value
4
title
TEAE with CTCAE Grade 5
categories
measurements
group Id
OG000
value
0
title
TEAE with CTCAE Grade 5 Related to Durva
categories
measurements
group Id
OG000
value
0
title
TEAE with CTCAE Grade 5 Related to Dara
categories
measurements
group Id
OG000
value
0
title
TEAE with CTCAE Gr 5 Related to Durva or Dara
denoms
counts
group Id
OG000
value
18
units
Participants
description
TEAEs include AEs between the earliest of the first dose date of either study drug and 90 days after the last dose of either study drug. In addition, an AE that occurred beyond the timeframe and was assessed by the doctor as possibly related to IP was considered to be treatment-emergent. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for AEs (NCI CTCAE) version 4.03, where 1= Mild; 2= Moderate; 3= Severe; 4= Life-threatening; 5= Death related to AE. Serious AEs resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in a medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes above.
groups
description
Participants received intravenous daratumumab at 16 mg/kg on the same dosing schedule (weekly, every 2 weeks, or every 4 weeks of each 28-day treatment cycle) on their last prior therapy containing daratumumab regimen. The dosing schedule for daratumumab could be adjusted during the course of the study, provided the participant had a response of stable disease or better. Participants also received IV durvalumab at 1500 mg on Day 2 of Cycle 1 and then on Day 1 of Cycles ≥ 2 of each 28-day treatment cycle. Participants could continue on study treatment until progressive disease or unacceptable toxicity.
id
OG000
title
Daratumumab and Durvalumab
param Type
COUNT_OF_PARTICIPANTS
population Description
The safety population consisted of all participants who received at least one dose of Durvalumab (Durva) or Daratumumab (Dara).
reporting Status
POSTED
time Frame
From the date of the first dose of study drug until 90 days after the last dose of durvalumab or daratumumab , whichever is later. Maximum overall time on treatment was 16 weeks for daratumumab and durvalumab
title
Participants With Treatment-Emergent Adverse Events (TEAEs)
Triangle