FEATURE
users (45.7%) stopped using them specifically because of the
high data entry burden, loss of interest, and hidden costs.
“The biggest concern that people have applies to
nutrition and activity behavior, as well as other kinds of
behaviors like medical adherence,” he said. “However,
when the user has to enter data, engagement with the app
lasts maybe three days.”
While the recent popularity of wearable sensors (i.e.,
the FitBit or the Apple Watch) has improved activitytracking (as data are passively collected), attempts to
automate medication adherence, such as through the use
General Disorders and Administration Site Conditions
Fatigue
109 (28%)
21 (5%)
104 (27%)
Pyrexia
93 (24%)
5 (1%)
64 (17%)
20 (5%)
1 (0%)
Edema Peripheral
63 (16%)
2 (1%)
57 (15%)
2 (1%)
Asthenia
53 (14%)
11 (3%)
46 (12%)
7 (2%)
3 (1%)
Infections and Infestations
Upper Respiratory Tract Infection
85 (22%)
7 (2%)
52 (13%)
Nasopharyngitis
63 (16%)
0
43 (11%)
0
Bronchitis
54 (14%)
5 (1%)
39 (10%)
2 (1%)
Pneumoniaa
54 (14%)
35 (9%)
43 (11%)
27 (7%)
12 (3%)
Metabolism and Nutrition Disorders
Hypokalemia
78 (20%)
22 (6%)
35 (9%)
Hypocalcemia
55 (14%)
10 (3%)
39 (10%)
5 (1%)
Hyperglycemia
43 (11%)
18 (5%)
33 (9%)
15 (4%)
88 (22%)
3 (1%)
73 (19%)
3 (1%)
43 (11%)
7 (2%)
37 (10%)
4 (1%)
63 (16%)
6 (2%)
50 (13%)
8 (2%)
Musculoskeletal and Connective Tissue Disorders
Muscle Spasms
Nervous System Disorders
Peripheral Neuropathies NECb
Psychiatric Disorders
Insomnia
Respiratory, Thoracic, and Mediastinal Disorders
Cough
85 (22%)
1 (0%)
46 (12%)
0
Dyspneac
70 (18%)
9 (2%)
58 (15%)
6 (2%)
45 (12%)
5 (1%)
53 (14%)
5 (1%)
Embolic and Thrombotic Events,
Venousd
49 (13%)
16 (4%)
22 (6%)
9 (2%)
Hypertensione
41 (11%)
12 (3%)
15 (4%)
4 (1%)
Skin and Subcutaneous Tissue
Disorders
Rash
Vascular Disorders
KRd = Kyprolis, lenalidomide, and low-dose dexamethasone; Rd = lenalidomide and
low-dose dexamethasone
a
Pneumonia includes preferred terms of pneumonia, bronchopneumonia
b
Peripheral neuropathies NEC includes preferred terms under HLT peripheral
neuropathies NEC
c
Dyspnea includes preferred terms of dyspnea, dyspnea exertional
d
Embolic and thrombotic events, venous include preferred terms in MedDRA SMQ
narrow scope search of embolic and thrombotic events, venous.
e
Hypertension includes preferred terms of hypertension, hypertensive crisis,
hypertensive emergency
There were 274 (70%) patients in the KRd arm who received treatment beyond Cycle 12.
There were no new clinically relevant AEs that emerged in the later treatment cycles.
Grade 3 and higher adverse reactions that occurred during Cycles 1-12 with a
substantial difference (≥2%) between the two arms were neutropenia, thrombocytopenia,
hypokalemia, and hypophosphatemia.
Laboratory Abnormalities
Grade 3–4 Laboratory Abnormalities ( ≥10%) in Cycles 1-12
(Combination Therapy)
KRd
(N = 392)
Rd
(N = 389)
Decreased Lymphocytes
182 (46%)
119 (31%)
Decreased Abso